Steerable endoluminal punch with cutting stylet

ABSTRACT

A transseptal needle or punch is described wherein the distal end of the transseptal needle is able to articulate laterally out of the longitudinal axis of the steerable transseptal needle. The transseptal needle includes a blunted distal end configuration that is minimally traumatic. Under control by the user or a computer, the transseptal needle can be articulated to generate various curves with high bending force. The transseptal needle is configured for use with an introducer which can also include side windows.

This application claims priority to U.S. Provisional Application62/546,247, filed Aug. 16, 2017. This application is acontinuation-in-part of U.S. application Ser. No. 15/441,025 filed Feb.23, 2017, pending, which claims priority to U.S. Provisional Application62/299,963, filed Feb. 25, 2016.

FIELD OF THE INVENTIONS

The invention relates to devices and methods for performing endovascularaccess to the cardiovascular system or other body vessels or bodylumens, especially procedures performed in the fields of cardiology,radiology, electrophysiology, and surgery.

BACKGROUND

The currently accepted procedure for left atrial access involves routinga needle called a Brockenbrough needle into the right atrium with theBrockenbrough needle pre-placed within a guiding catheter. The guidingcatheter specifically preferred for use with a Brockenbrough needle iscalled a Mullins catheter or transseptal introducer. The Brockenbroughneedle is a long, small diameter punch, generally formed from astainless steel wire stylet that is surrounded by a stainless steeltube.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a trans-septal punch assembled so thatthe inner tube is bent in a direction 180 degrees opposite that of theouter tube, resulting in a substantially straight punch configuration,according to an embodiment of the invention;

FIG. 2 illustrates a side view of the disassembled trans-septal punchshowing the central core wire or stylet, the inner tube bent in onedirection and the outer tube bent in another direction, according to anembodiment of the invention;

FIG. 3 illustrates a side view of the trans-septal punch assembled sothat the inner tube bend is aligned in the same direction as the outertube bend, resulting in a curved distal end on the punch assembly,according to an embodiment of the invention;

FIG. 4 illustrates a side view of a trans-septal punch comprising aflexible region proximal to the distal end and pull-wires disposedbetween the distal end and the proximal end of the punch, according toan embodiment of the invention;

FIG. 5 illustrates a side view of the trans-septal punch of FIG. 4wherein one of the pull-wires is placed in tension causing the distalflexible region of the punch to deflect into an arc away from thelongitudinal axis of the punch, according to an embodiment of theinvention;

FIG. 6 illustrates an adjustable, spacer, which sets and maintains thedistance between the distal end of the punch hub and the proximal end ofa guide catheter hub, according to an embodiment of the invention;

FIG. 7A illustrates a side, partial breakaway, view of an outer tube ofan articulating trans-septal punch comprising a plurality of slots nearthe distal end to generate a region of increased flexibility, accordingto an embodiment of the invention;

FIG. 7B illustrates a side, partial breakaway, view of an intermediate,or inner, tube of an articulating trans-septal punch comprising alongitudinal slot dividing the tube into two axially oriented partswhich are connected at the distal end of the inner tube, according to anembodiment of the invention;

FIG. 8 illustrates a cross-sectional view of the proximal end of thearticulating trans-septal punch comprising a stopcock and a bendadjusting mechanism, according to an embodiment of the invention;

FIG. 9 illustrates a partial breakaway view of the distal end of thearticulating trans-septal punch comprising the outer tube and the innertube arranged concentrically and oriented circumferentially, accordingto an embodiment of the invention;

FIG. 10 illustrates an oblique view of the proximal end of thearticulating trans-septal punch, according to an embodiment of theinvention;

FIG. 11 illustrates a side view of the distal end of the articulatingtrans-septal punch incorporating a control rod and a control rodretainer, separated from each other, and the outer T-slotted tube withthe inner tube being pulled proximally relative to the outer tubecausing the outer tube to deform into a curve having very stiff, orrigid, mechanical properties, according to an embodiment of theinvention;

FIG. 12A illustrates a top view of a portion of the distal flexibleregion of an outer tube comprising dovetails or interlocking grooves toreduce torque or side-to-side motion, according to an embodiment of theinvention;

FIG. 12B illustrates a side view of a portion of the outer tube distalflexible region of an outer tube comprising dovetails or locking groovesto reduce torque or side-to-side motion, according to an embodiment ofthe invention;

FIG. 13 illustrates the distal end of an articulating septal punchadvanced nearly to the distal end of an obturator or dilator, which iscoaxially, removably assembled into the central lumen of a guidecatheter sheath, according to an embodiment of the invention;

FIG. 14 illustrates the distal end of an articulating transseptal punchfurther comprising a removable obturator having a collapsible distalshield, according to an embodiment of the invention;

FIG. 15A illustrates an outer tube cut in its flexible regions withshorter lateral slots and with reduced or complete elimination of someT-slots to improve resistance to bending in that region, according to anembodiment of the invention;

FIG. 15B illustrates a control rod without any control rod retainerleaving only the c-shaped control rod and the distal end, according toan embodiment of the invention;

FIG. 16A illustrates a cross-sectional view of a control rodconfiguration in a steerable transseptal punch within the flexibleregion, wherein the separation between the control rod and a control rodretainer is substantially at the midpoint or center of the outer tube,according to an embodiment of the invention;

FIG. 16B illustrates a lateral cross-section of a tubing configurationof a steerable transseptal punch within the flexible distal region, withan off-center slot, according to an embodiment of the invention;

FIG. 17A illustrates a cross-sectional view of a steerable transseptalpunch comprising an outer tube and three control rods, each subtendingapproximately ⅓ of the internal circumference of the outer tube, some orall of which can be functional and each of which is separated from theother by the spacing and all residing within the central lumen of theouter tube, according to an embodiment of the invention;

FIG. 17B illustrates a cross-sectional view of a steerable transseptalpunch comprising an outer tube and four control rods, each subtendingapproximately ¼ of the internal circumference of the outer tube, some orall of which can be functional and each of which is separated from theother by the spacing and all residing within the central lumen of theouter tube, and further including an innermost tube to control the fluidpath and prevent ingress of egress of fluid from the central lumen ofthe punch assembly, according to an embodiment of the invention;

FIG. 18A illustrates a lateral cross-section of a steerable transseptalpunch comprising an outer tube, a control rod, a control rod retainer,an internal pressure sleeve to prevent ingress or egress of fluids, anda stylet, according to an embodiment of the invention;

FIG. 18B illustrates a lateral cross-section of a steerable transseptalpunch comprising an outer tube, two control rods subtending ½ of theinternal circumference of the inner lumen and a control rod retainersubtending ½ of the internal circumference of the outer tube, along witha central stylet, according to an embodiment of the invention;

FIG. 18C illustrates a side view of a control rod and keeper systemcomprising a c-shaped control rod and a c-shaped control rod guide,retainer, or keeper configured to maintain the control rod against theinside diameter of an outer tube and further comprising ends configuredfor welding and providing a fluid-tight seal with other structureswithin a punch, according to an embodiment of the invention.

FIG. 19A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube and a control rod in the shape of a “V”or “L”, according to an embodiment of the invention;

FIG. 19B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube and a control rod in the shape of an openended box or “U”, according to an embodiment of the invention;

FIG. 20A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube and two hollow control rods, each ofwhich having a circular cross-section, according to an embodiment of theinvention;

FIG. 20B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube, two hollow control rods, and a stylet,each of which comprising a circular cross-section, according to anembodiment of the invention;

FIG. 21A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube, a rectangular control rod with roundedends and a round stylet within a lumen of the control rod, according toan embodiment of the invention;

FIG. 21B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube and an I-beam shaped control rod,according to an embodiment of the invention;

FIG. 22A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen and a control roddisposed within the central lumen, according to an embodiment of theinvention;

FIG. 22B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube, a hollow control rod disposed within thelumen of the outer tube, and a stylet disposed within the lumen of thecontrol rod, according to an embodiment of the invention;

FIG. 23A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen and a control roddisposed within the central lumen, the control rod having a centrallumen and two channels to retain the one or more control wires or rods,according to an embodiment of the invention;

FIG. 23B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube, a control rod, and a control rod guide,the guide and the control rod being separated by slots formed at anangle other than radial, according to an embodiment of the invention;

FIG. 24A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a control roddisposed within the central lumen of the outer tube, the control rodhaving a central lumen and subtending less than a full circlecircumferentially, and a central stylet, according to an embodiment ofthe invention;

FIG. 24B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube, a c-shaped control rod, and a controlrod guide having thinner wall than the control rod, the guide and thecontrol rod being separated by slots formed radially, according to anembodiment of the invention;

FIG. 25A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a c-shapedcontrol rod disposed within the central lumen of the outer tube, ac-shaped control rod retainer, and narrow slots separating the controlrod and the retainer, according to an embodiment of the invention;

FIG. 25B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a c-shapedcontrol rod disposed within the central lumen of the outer tube, ac-shaped control rod retainer, and medium width slots separating thecontrol rod and the retainer, according to an embodiment of theinvention;

FIG. 25C illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a c-shapedcontrol rod disposed within the central lumen of the outer tube, ac-shaped control rod retainer, extremely wide slots separating thecontrol rod and the retainer, and a large gap between the OD of thecontrol rod and retainer and the ID of the outer tube, according to anembodiment of the invention;

FIG. 26A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a plurality ofcontrol rods or wires, an inner tube, and a central stylet, according toan embodiment of the invention;

FIG. 26B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a plurality ofhollow tubular control rods or wires, an inner tube, and a centralstylet, according to an embodiment of the invention;

FIG. 27A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen and a solidcentral control rod slidably disposed therein, according to anembodiment of the invention;

FIG. 27B illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen, a semi-circularfirst solid control rod, and a semi-circular solid control rod retaineror second control rod, according to an embodiment of the invention;

FIG. 28A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen and a plurality ofradially oriented cuts or grooves disposed in two generally orthogonaldirections, the different cuts or grooves being interdigitated betweeneach other along the length of a flexible region, a plurality of controlrods and a control rod retainer, according to an embodiment of theinvention;

FIG. 28B illustrates a lateral cross section of the steerabletransseptal punch comprising an outer tube having a central lumen, twoquarter-circular arcuate control rods, and a semi-circular hollowcontrol rod retainer, according to an embodiment of the invention;

FIG. 29A illustrates a lateral cross section of a steerable transseptalpunch comprising an outer tube having a central lumen and a plurality ofradially oriented cuts or grooves disposed in two generally orthogonaldirections, the different cuts or grooves being placed in order with thegrooves in the first direction in a different axial region of the tubethan the grooves in the second direction and each defining a flexibleregion in a specific direction, a plurality of control rods, a pluralityof distal weld points, and a control rod retainer, according to anembodiment of the invention;

FIG. 29B illustrates a lateral cross section of the steerabletransseptal punch comprising an outer tube having a central lumen, twoquarter-circular arcuate control rods, and a semi-circular hollowcontrol rod retainer, according to an embodiment of the invention;

FIG. 30A illustrates a lateral cross section of a steerable transseptalneedle comprising an outer tube having a central lumen and a pluralityof radially oriented openings, cuts, or grooves disposed in a singledirection, defining a flexible region in a specific direction, a hollowcircular control rod, a distal weld point between the control rod andthe outer tube, a pressure jacket over the openings in the outer tube toprevent fluid leakage or ingress, and a distal hinge on the control rod,according to an embodiment of the invention;

FIG. 30B illustrates a lateral cross section of the steerabletransseptal punch comprising an outer tube having a central lumen and ahollow circular, tubular control rod having a central lumen, accordingto an embodiment of the invention;

FIG. 31A illustrates a side view of a steerable transseptal needlecomprising a blunt distal end and a sharp, tissue piercing stylet orobturator, in its retracted state, according to an embodiment of theinvention;

FIG. 31B illustrates a side view of the steerable transseptal needle ofFIG. 31A with the sharp stylet or obturator advanced distally beyond thedistal end of the inner tube to form a sharp, tissue punch, according toan embodiment of the invention;

FIG. 32A illustrates a steerable transseptal needle comprising aradiopaque marker at the distal end of the inner tube as well as a smalldiameter segment of the stylet wire, according to an embodiment of theinvention;

FIG. 32B illustrates the steerable transseptal needle of FIG. 32A withthe stylet advanced out the distal end of the inner tube, according toan embodiment of the invention;

FIG. 33A illustrates a steerable transseptal needle comprising a beveledtip, sharp stylet, according to an embodiment of the invention;

FIG. 33B illustrates the steerable transseptal needle of FIG. 33A withthe beveled sharp stylet advanced out the distal end of the inner tube;

FIG. 34A illustrates a hub configured for use with a piercing stylet orobturator in its retracted state, according to an embodiment of theinvention;

FIG. 34B illustrates the hub of FIG. 34A actuated such that the styletor obturator is advanced a controlled distance, according to anembodiment of the invention;

FIG. 35A illustrates a side exterior view of a stylet hub furthercomprising a removable safety clip, according to an embodiment of theinvention;

FIG. 35B illustrates the hub of FIG. 35A in oblique view, according toan embodiment of the invention;

FIGS. 36A, 36B and 36C illustrate a side view of a steerable transseptalneedle with a piercing stylet hub removably affixed to the proximal endof the needle hub, according to an embodiment of the invention;

FIG. 37 illustrates a top view of a steerable transseptal needlecomprising a three-way stopcock affixed to its hub, rather than thestandard one-way stopcock, according to an embodiment of the invention;

FIG. 38 illustrates a faceted sharp distal end of a piercing stylet,according to an embodiment of the invention;

FIG. 39A illustrates a side, partial breakaway view of the distal end ofa steerable transseptal needle wherein a portion of the stylet shaft hasbeen cut away to facilitate fluid flow within the central lumen of thesteerable transseptal needle, according to an embodiment of theinvention;

FIG. 39B illustrates a lateral cross-section of a stylet wire configuredto facilitate fluid flow or pressure measurement while the stylet wireis in place within the steerable transseptal needle lumen, according toan embodiment of the invention;

FIG. 40 illustrates a hub of a steerable transseptal needle safetypiercing stylet wherein the hub comprises magnetic latches to actuatethe stylet, according to an embodiment of the invention;

FIG. 41 illustrates the hub of a steerable medical device wherein thehub comprises two separate jackscrews, affixed to separate control rods,and moving axially in opposite directions under the control of a knoband an optional stepper motor, according to an embodiment of theinvention;

FIG. 42A illustrates a steerable needle or medical device, in itsstraightened configuration, comprising two regions of flexibilityseparated by a non-flexible segment, according to an embodiment of theinvention;

FIG. 42B illustrates the steerable needle or medical device of FIG. 42Ain a curved or articulated orientation, according to an embodiment ofthe invention;

FIG. 43A illustrates a side view, in partial cutaway, of the distal endof a steerable needle further comprising a stylet that is configured tocut tissue but with the cutting element retracted, according to anembodiment of the invention;

FIG. 43B illustrates a side view, in partial cutaway, of the distal endof the steerable needle further comprising the cutting stylet as shownin FIG. 43A but with the cutting element of the stylet actuated so as toproject radially outward, according to an embodiment of the invention;

FIG. 44A illustrates a side view, in partial cutaway, of the distal endof a steerable needle further comprising a cutting stylet comprising awindow and a plurality of retracted expandable blades, according to anembodiment of the invention;

FIG. 44B illustrates a side view, in partial cutaway, of the distal endof the steerable transseptal needle of FIG. 44A with the plurality ofcutting blades radially expanded, according to an embodiment of theinvention;

FIG. 45 illustrates a side view of the distal end of a steerabletransseptal needle comprising a cutting stylet wire that is split intotwo blades biased radially outward so as to project laterally when thestylet wire is exposed beyond the end of the steerable transseptalneedle, according to an embodiment of the invention;

FIG. 46 illustrates the proximal end of a steerable transseptal needlewith a hub, wherein the hub includes a radiofrequency generator, a powersupply, and a switch to actuate the system, according to an embodimentof the invention;

FIG. 47A illustrates the distal end of a piercing stylet for use with atransseptal needle, wherein the piercing stylet comprises a hollowtubular construction to permit flow therethrough as well as a radiopaquemarker positioned near the distal tip of the stylet, according to anembodiment of the invention;

FIG. 47B illustrates the proximal end of the piercing stylet of FIG.47A, showing the hollow tubular structure and a window disposed near theproximal end to allow for infusion or withdrawal of fluids within thehollow tubular structure, according to an embodiment of the invention

FIG. 48A illustrates a side partial cross-sectional view of the proximalend of a steerable transseptal needle with a side port and a disengagingjackscrew traveler, according to an embodiment of the invention;

FIG. 48B illustrates a view of the proximal end of the steerabletransseptal needle of FIG. 48A, according to an embodiment of theinvention;

FIG. 49A illustrates a side, partial cutaway view of an introducersheath comprising a window in its side wall proximate the distal end andfurther comprising a window in the side wall of the dilator in the sameregion as the window in the side wall of the introducer, according to anembodiment of the Invention;

FIG. 49B illustrates a side view of the punch system wherein anarticulating endoluminal punch, in its straightened configuration, hasbeen advanced such its distal end and articulating portion are alignedwith the side windows of the sheath and dilator, according to anembodiment of the invention;

FIG. 49C illustrates a view of the punch system of FIG. 49B wherein thepunch has been articulated sideways through the side window, furtherwherein the support structure provides backup support for the punch toallow lateral force to be applied to tissue being incised, according toan embodiment of the invention;

FIG. 50A illustrates a steerable endoluminal punch having a distal endthat can be reconfigured from a first, more blunted or atraumatic shape(as illustrated) into a second shape, which is configured to be sharperand more capable of cutting tissue, according to an embodiment of theinvention;

FIG. 50B illustrates the reconfigurable distal end of the steerableendoluminal punch with its distal end having been reconfigured into asharper shape, according to an embodiment of the invention;

FIG. 50C illustrates the punch of FIG. 50B wherein the stylet controlrod has been advanced distally;

FIG. 51A illustrates the distal end of a steerable endoluminal punchcomprising a conic section; according to an embodiment of the invention;

FIG. 51B illustrates the distal end of a steerable endoluminal punchwhich includes the conic section of FIG. 51A combined with a bevel tocreate a sharp edge that is displaced radially inward from the outerdiameter of the steerable endoluminal punch, according to an embodimentof the invention;

FIG. 52 illustrates the distal end of a steerable endoluminal punchcomprising a blunted stylet that protects the walls of a catheter fromthe sharp edge of the endoluminal punch, according to an embodiment ofthe invention;

FIG. 53 illustrates a steerable endoluminal punch being used to accessthe fossa ovalis of the heart by way of a superior approach through thesuperior vena cava and an access point cranial to the superior venacava, according to an embodiment of the invention;

FIG. 54A illustrates a steerable endoluminal punch having a 4-pointedcrown-shaped sharp distal end configured to penetrate tissue with andwithout the use of a central punch, according to an embodiment of theinvention; and

FIG. 54B illustrates a steerable endoluminal punch having a two-pointcrown-shaped sharp distal end configured to penetrate tissue with andwithout the use of a central punch, according to an embodiment of theinvention.

FIG. 55 illustrates the distal end of a steerable endoluminal punchsystem comprising a cutting stylet with laterally biased cutting blades.

FIGS. 56A and 56B illustrate a cutting introducer.

DETAILED DESCRIPTION

In accordance with current terminology pertaining to medical devices,the proximal direction will be that direction on the device that isfurthest from the patient and closest to the user, while the distaldirection is that direction closest to the patient and furthest from theuser. These directions are applied along the longitudinal axis of thedevice, which is generally an axially elongate structure having one ormore lumens or channels extending through the proximal end to the distalend and running substantially the entire length of the device.

In an embodiment, the punch comprises an inner core wire or stylet, aninner tube and an outer tube. In an embodiment, the stylet can beremovable or non-removable. The punch further comprises a hub at itsproximal end which permits grasping of the punch and also includes astopcock or valve to serve as a lock for the stylet, or inner core wire,as well as a valve for control of fluid passage into and out from theinnermost lumen within which the stylet or inner core wire resides. Theproximal end further comprises one or more control handles to manipulatethe amount of articulation at the distal end of the catheter. Theproximal end further is terminated with a female Luer or Luer lock port,which is suitable for attachment of pressure monitoring lines, dyeinjection lines, vacuum lines, a combination thereof, or the like.

In another embodiment, steerability can be obtained using actuators onthe surface or within the interior of the cannula to force bending ofthe cannula. These actuators can be typically electrically powered. Inan embodiment, an actuator can comprise electrical leads, a powersource, a compressible substrate, and shape memory materials such asnitinol. Such actuators may be distributed along the length of thecannula. The actuators may be placed so as to oppose each other.Opposing actuators are activated one at a time and not simultaneouslyand can generate a steering effect or back and forth motion.

Other embodiments of the inventions comprise methods of use. One methodof use involves inserting the central core wire or stylet so that itprotrudes out the distal end of the punch. A percutaneous or cutdownprocedure is performed to gain access to the vasculature, either a veinor an artery. An introducer and guidewire are placed within thevasculature and the guidewire is routed proximate to the targettreatment site. The introducer can be removed at this time. A guidingcatheter, preferably with a removable central obturator or dilator, witha tapered distal tip pre-inserted, is routed over the guidewire to thetarget site. In some embodiments, the guide catheter is routed throughfrom a femoral vein, through the inferior vena cava, and into the rightatrium of the heart. In an embodiment, the target site can be the atrialseptum of the heart in the region of the Fossa Ovalis. In someembodiments, the guide catheter distal tip is routed past the rightatrium and into the superior vena cava. The guidewire can be removed atthis time. The punch is adjusted so that it assumes a substantiallystraight configuration. The punch can be advanced through the centrallumen of the already placed catheter, sheath, introducer, or guidecatheter. By making the punch as straight as possible, there is nocurvature to force the sharpened distal edges of the punch to scrape theinside of the catheter lumen as the punch is advanced distally insidethe guide catheter and potentially dislodge or skive away debris ormaterial which could cause embolic effects to the patient. Carefullyensuring that the punch does not protrude beyond the distal end of thecatheter or its obturator, the punch is next deflected so that it formsa curve. The distal end of the punch is sufficiently radiopaque that itis observable clearly under fluoroscopy or X-ray imaging. The locationof the punch and the amount of deflection and curvature of the distalend are observed and controlled using the aforementioned fluoroscopy orX-ray imaging, or other imaging method such as MRI. The curve isoriented so that it is medially directed toward the atrial septum.Alignment with any curvature of the catheter can be completed at thistime. The punch and guide catheter/obturator are withdrawn caudally, asa unit, into the right atrium from the superior vena cava. The punch andguide catheter are positioned using fluoroscopy or other imaging systemagainst the Fossa Ovalis. The Fossa Ovalis is a relatively thinstructure and the force of the punch will tent the Fossa Ovalis towardthe left atrium. In one embodiment, the central core wire or stylet,initially advanced, can next be withdrawn to expose the sharp distaledge of the punch. When correctly positioned under fluoroscopy,ultrasound, or other imaging system, dye can be injected into thecentral lumen of the punch at its proximal end and be expelled out ofthe distal end of the punch and obturator to paint or mark the FossaOvalis. A generally “V-shaped” mark can be observed under fluoroscopy,which denotes the location of the Fossa Ovalis. The curvature of thepunch can be increased or decreased by articulation to gain optimalalignment with the Fossa Ovalis. This steering function can be verybeneficial in device placement.

Maintaining the position of the guiding catheter against the FossaOvalis, the punch is advanced distally against and through the atrialseptum, in the region of the Fossa Ovalis, so that it penetrates andprotrudes into the left atrium. In order to stabilize the atrial septaltissue prior to coring, a distally protruding corkscrew tipped wire or avacuum head operably connected to the proximal end of the punch, can beused to grasp and retract the septal tissue. Once the initialpenetration is completed, the guide catheter is next advanced, with itstapered obturator leading the way, across the atrial septum until itresides within the left atrium. The tapered obturator or dilator alongwith the punch can be removed at this time to allow for catheterplacement through the guiding catheter. In another embodiment, acalibrated spacer can be used between the guide catheter hub and thepunch hub to ensure that the punch does not protrude beyond the distalend of the guide catheter tip until the desired time for punching thehole. At this point, the spacer is unlocked and removed from the punchor catheter. In some embodiments, the punch is removed from the guidecatheter and the same punch is routed through a second guide catheter toprovide access to the left atrium for the second guide catheter. Twoguide catheters are often necessary for ablation procedures because oneguide catheter is used to route mapping and diagnostic devices into theleft atrium while the second guide catheter is used to route therapeuticcatheters into the left atrium. Thus, the punch can be used more thanonce on a given patient but, for prevention of contamination, the samepunch should not be used on different patients because cleaning andsterilization after use is nearly impossible given the small distancesbetween the moving inner and outer tubes which can hide contaminationfrom cleaning or sterilization by the user.

In another embodiment, the core wire, obturator or stylet is sharpenedand serves as a tissue punch. In this embodiment, the distal end of thehollow tubes of the punch are blunted and made relatively atraumatic.Once the core wire punch has completed tissue penetration, the outertubes are advanced over the central punch wire through the penetrationand into the left atrium. In another embodiment, a pressure monitoringdevice such as a catheter tip pressure transducer, or a pressure lineterminated by a pressure transducer, can be affixed to a quick connect,generally a Luer fitting, at the proximal end of the punch hub. Bymonitoring pressure, it is possible to determine when the distal end ofthe punch has passed from, for example, the right atrium into the leftatrium, because the pressure versus time curves in these two chambersare measurably, or visually, different. The proximal end of the hubfurther has provision for attachment to a dye injection line for use ininjecting radiographic contrast media through the central lumen of thepunch. Typically a manifold can be attached to the Luer fitting on theproximal end of the hub, the manifold allowing for pressure monitoring,for example on a straight through port, and for radiopaque dyeinjection, for example through a side port. A stopcock, or other valve,can be used to control which port is operably connected to the centrallumen of the punch.

In some embodiments, the inner tube, the outer tube, or both can haveslots imparted into their walls to impart controlled degrees offlexibility. The slots can be configured as “snake cuts” to form aseries of ribs with one or more spines. The spines can be oriented at agiven circumferential position on the outer tube, the inner tube, orboth. The spines can also have non-constant orientations. In someembodiments, only the outer tube is slotted. The slots can be generatedwithin the distal portion of the outer tube where the curve isgenerated. This distance can range between 3-cm and 15-cm of the end andpreferably between 7-cm and 12-cm of the distal end. The slot widths canrange between 0.001 inches and 0.100 inches with a preferable width of0.003 to 0.025 inches. In exemplary embodiments, the slot widths areabout 0.010 inches. In some embodiments, it is desirable to have theouter tube bend in one direction only but not in the opposite directionand not in either lateral direction. In this embodiment, cuts can bemade on one side of the outer tube within, for example, the distal 10-cmof the tube length. Approximately 10 to 30 cuts can be generated with awidth of approximately 0.010 to 0.040 inches. The cut depth, across thetube diameter from one side, can range between 0.1 and 0.9 of the tubediameter. In an embodiment, the cut depth can be approximately 0.4 to0.6 of the tube diameter with a cut width of 0.025 inches. A second cutcan be generated on the opposite side of the tube wherein the second cutis approximately 0.005 inches or less. In an embodiment, the outer tubecan be bent into an arc first and then have the slots generated suchthat when the tube is bent back toward the 0.005 inch wide cuts, thetube will have an approximately straight configuration even through eachtube segment between the cuts is slightly arced or curved.

FIG. 1 illustrates a side view of a punch, needle, or catheter assembly100, with an integral articulating or bending mechanism. The punchassembly 100 comprises a stylet or obturator wire 102, an inner tube104, an outer tube 106, an obturator grasping tab 108, a stopcock 110,an inner tube pointer 112, an outer tube pointer 114, an inner tube hub116, and an outer tube hub 118.

Referring to FIG. 1, the obturator wire 102 is affixed to the obturatorgrasping tab 108. The stylet or obturator wire 102 is inserted throughthe central lumen of the inner tube 104 and is slidably disposedtherein. The stopcock 110 is affixed to the inner tube hub 116 and thethrough lumen of the stopcock 110 is operably connected to the centrallumen of the inner tube 104. The inner tube pointer 112 is affixed tothe inner tube hub so that it is visible to the user. The outer tubepointer 114 is affixed to the outer tube hub 118 so that it is visibleto the user. The inner tube hub 116 and the inner tube 104 are able torotate about the longitudinal axis within the outer tube hub 118 and theouter tube 106. In an embodiment, the inner tube 104 is restrained fromlongitudinal motion relative to the outer tube 106. In this embodimentand other embodiments in which the inner tube is fixed to the outertube, the inner tube may be longitudinally fixed to the outer tube at apoint distal to the “flexible region” of the outer tube, but notlongitudinally fixed to the outer tube at any point proximal to the“flexible region” so that the inner tube and outer tube can be tensionedrelative to each other to affect bending of the “flexible region.” Inanother embodiment, the inner tube 104 can be advanced distally relativeto the outer tube 106. In this latter embodiment, advancement of theinner tube 104 can be used to facilitate punching. The distal end of theinner tube 104 can be sharpened and serve as a punch. The distal end ofthe inner tube 104 is sheathed inside the outer tube 106 to protect thetissue from the sharp distal edge of the inner tube 104 until the innertube 104 is advanced distally outside the distal end of the outer tube106. A releasable lock can be used to maintain the axial or longitudinalposition of the inner tube 104 relative to the outer tube 106 untilpunching is required. A releasable lock can further be used to maintainthe rotational position of the inner tube hub 116 and thus the innertube 104 relative to the outer tube hub 118 and the outer tube 106.

All components of the punch assembly 100 can be fabricated from metalssuch as, but not limited to, stainless steel, Elgiloy™, cobalt nickelalloy, titanium, nitinol, or the like. The nitinol can be shape-memoryor it can be superelastic. The metals used in the obturator wire 102,the inner tube 104 and the outer tube 106 are advantageously coldrolled, heat treated, or otherwise processed to provide a full springhardness. The inner tube 104, the outer tube 106, or both, arerelatively rigid, resilient structures. Polymeric materials, such as,but not limited to, polycarbonate, ABS, PVC, polysulfone, PET,polyamide, polyimide, and the like, can also be used to fabricate thestopcock 110, the inner tube hub 116, the outer tube hub 118, the innertube pointer 112, and the outer tube pointer 114. The materials arebeneficially radiopaque to maximize visibility under fluoroscopy duringthe procedure. Additional radiopaque markers fabricated from tantalum,platinum, iridium, barium sulfate, and the like can be added to improvevisibility if needed. The inner tube 104 is curved or bent near itsdistal end into a gentle curve, preferably with a radius of between 1 to5 inches and so that the distal tip is deflected through an angle ofapproximately 10 to 90 degrees from the longitudinal axis of the innertube 104. The outer tube 106 is curved or bent near its distal end intoa gentle curve, preferably with a radius of between 1 to 5 inches and sothat the distal tip is deflected through an angle of approximately 10 to90 degrees from the longitudinal axis of the outer tube 106. The innertube hub 116 is welded, silver soldered, bonded, crimped, or otherwisefastened to the proximal end of the inner tube 104 so that the innertube pointer 112 points in the direction of the bend in the inner tube104. The outer tube hub 118 is welded, silver soldered, bonded, crimped,or otherwise fastened to the proximal end of the outer tube 106 so thatthe outer tube pointer 114 points in the direction of the bend in theouter tube 106. When the inner tube pointer 112 is oriented 180 degreesaway from the direction of the outer tube pointer 114, the bend in theinner tube 104 substantially counteracts or opposes the bend of theouter tube 106 and the coaxial assembly 100 is substantially straight,as shown in FIG. 1. The stopcock 110 can also be a ring seal,Tuohy-Borst valve, membrane valve, hemostasis valve, gate valve, orother valve, generally, but not necessarily manually operated. Thestiffness of the inner tube 104 and the outer tube 106 are sufficientthat the punch can be used as a guide for other catheters through whichthe punch 100 is passed and will deflect those catheters, even ones thathave thick walls and high resistance to bending.

FIG. 2 illustrates a side view of a stylet or obturator 140 furthercomprising the obturator wire 102 and the obturator-grasping tab 108.The obturator wire 102 is blunted at its distal end to render it asatraumatic as possible. In another embodiment, the obturator wire 102can be tapered in diameter to render it very flexible and thereforeatraumatic at its distal end. The obturator wire 102, in anotherembodiment, can be sharpened and serve as a needle or primary punchingmechanism. FIG. 2 also illustrates an intermediate punch assembly 120further comprising the inner tube 104, the stopcock 110, the inner tubepointer 112, the inner tube hub 116, an inner tube seal 124, an innertube pointer ball 126, a through lumen port 128, a beveled distal tip132, and a pre-set curve 136. FIG. 2 further illustrates an outer tubeassembly 122 further comprising the outer tube 106, the outer tube hub118, the outer tube pointer 114, an outer tube distal curve 130, and anouter tube pointer ball 134.

Referring to FIG. 2, the obturator-grasping tab 108 is affixed, eitherintegral to, silver soldered, welded, crimped, adhered, pinned, orotherwise attached, to the proximal end of the obturator wire 102. Theinner tube 104 is affixed to the inner tube hub 116 by silver soldering,welding, potting, crimping, setscrew, pin, or other fixation method,such that the hub 116 rotates 1 to 1 with the inner tube 104. Anoptional inner tube pointer ball 126 is affixed to the inner tubepointer 112 and provides additional visual and tactile rotationalpositioning sense for the intermediate punch or needle assembly 120. Acurve or bend 136 is heat set, or cold worked into the inner tube 104 ator near its distal end. The distal end of the inner tube 104 comprises abevel 132 which helps serve as a punch or cutting edge for the innertube 104. The angle of the bevel 132 can range between 20 and 70 degreesfrom the direction perpendicular to the longitudinal axis of the innertube 104. In another embodiment, the bevel is removed and the distal tipof the inner tube 104 is a gentle inward taper or fairing movingdistally that serves as a dilator should the obturator wire 102 be usedas the punching device rather than the blunt distal tip obturator of theinner tube 104.

In yet another embodiment, the distal tip can comprise a conic sectionthat can be further beveled. For example a 5 degree conic can be appliedto the distal tip of the inner tube such that a very thin flat edgeexists at the distal tip. This cone angle can range between about1-degree to about 10-degrees. This flat edge can be beneficially set atbetween 0.001 and 0.005 inches with a preferred dimension of between0.001 and 0.003 inches. This distal tip can then be further beveled tocreate a controlled amount of sharpness. In certain embodiments, thewall thickness of the tubing ranges from about 0.002 to 0.010 incheswith a preferred range of about 0.003 and 0.007 inches. The conicsection moves the sharp region of the distal tip radially inward so thatit is not directly at the exterior of the tube and thus, the inner tubedistal end is less likely to scrape on the interior walls of anycatheters through which it is inserted. The heel or most proximal partof the beveled tubing can further be buffed or rounded to minimizesharpness at that location. The other edges of the beveled end, otherthan at the pointed tip can also be beveled to reduce sharpness in allareas except for the distal most portion of the bevel.

The inner tube hub 116 further comprises a circumferential groove withan “0” ring 124 affixed thereto. The “0” ring 124 serves to form a fluid(e.g. air, blood, water) tight seal with the inner diameter of the outersheath hub 118 central lumen and allows for circumferential rotation ofthe inner tube hub 116 within the outer tube hub 118. The “0” ring 124can be fabricated from rubber, silicone elastomer, thermoplasticelastomer, polyurethane, or the like and may be lubricated with siliconeoil or similar materials. The stopcock 110 can be a single way or athree-way stopcock without or with a sideport, respectively.

The outer punch assembly 122 comprises the bend 130, which is heat setor cold worked into the outer tube 106 in the same longitudinal locationas the bend 136 of the inner tube. The wall thicknesses of the innertube 104 and the outer tube 106 are chosen to provide bending forcesthat cancel out when the curves 136 and 130 are oriented in oppositedirections and the inner tube 104 is inserted fully into the outer tube106. The wall thickness of the outer tube 106 and the inner tube 104 canrange between 0.003 inches and 0.20 inches, preferably ranging between0.004 and 0.010 inches. The outer diameter of the outer tube 106 canrange between 0.014 and 0.060 inches and preferably between 0.025 and0.050 inches. In a most preferred embodiment, the outside diameter ofthe outer tube 106 is about 0.048 inches. The outer diameter of theobturator wire 102 can range between 0.005 and 0.030 inches andpreferably range between 0.010 and 0.020 inches.

FIG. 3 illustrates a side view of the punch assembly 100 fully assembledand aligned so that both the inner tube distal curve 136 (Refer to FIG.2) and the outer tube distal curve 130 are aligned in the same directionresulting in a natural bend out of the axis of the punch 100. The punchassembly 100 comprises the obturator wire 102, the inner tube 104, theouter tube 106, the obturator grasping tab 108, the stopcock 110, theinner tube pointer 112, the outer tube pointer 114, the inner tube hub116, the inner tube pointer ball 126, and the outer tube pointer ball134.

Referring to FIG. 3, the outer tube pointer 114 and inner tube pointer112 are aligned together and in this configuration, the tubing assemblypossesses its maximum curvature, which is oriented in the samedirections as the pointers 112 and 114. The pointer balls 126 and 134are aligned together to provide additional tactile and visual indices ofcurvature direction. In an embodiment, the curvature of the tubeassembly 104 and 106 is unbiased with no net force exerted therebetweenand an angle of approximately 45 degrees is subtended by the device inthe illustrated configuration. Further curvature can also occur out ofthe plane of the page so that the curvature takes on a 3-dimensionalshape, somewhat similar to a corkscrew. In another embodiment, thecurvature of the aligned inner tube 104 and the outer tube 106 subtendsan angle of 90-degrees or greater. Again, the inner tube 104 and theouter tube 106 have stiffness sufficient that the assembly is capable ofguiding any catheter through which the punch 100 is passed. In anotherembodiment, the inner tube 104 and the outer tube 106 have differentdegrees of curvature so that when they are aligned, a net force still isgenerated between the two tubes, although a maximum curvatureconfiguration is still generated. This embodiment can be advantageous inpermitting articulation in a direction away from the direction ofprimary curvature. The radius of curvature of the punch 100 can rangefrom substantially infinity, when straight, to as little as 0.5-cm, witha preferred range of infinity to as little as 2-cm radius when fullycurved or articulated. One embodiment permits a substantially infiniteto a 3-cm radius of curvature. The overall working length of the punch,that length from the proximal end of the outer tube hub to the distalmost end of the punch, can range from 10 to 150-cm and preferablybetween 60 and 100-cm, with a most preferred range of between 70 and90-cm. A preferred curve has a radius of about 3-cm and is bent into anarc of about 45 to 90 degrees.

FIG. 4 illustrates a side view of another embodiment of a needle orpunch assembly 400 comprising an obturator wire 102, an obturator wiregrasping tab 108, a stopcock 110, an inner tube 404, an outer tube 406,a plurality of deflecting wires 412, an outer tube hub 414, a deflectinglever 416, a weld 420, an axis cylinder 424, a plurality of deflectingwire channels 426, and a flexible region 430. The distal end of theregion just proximal to the flexible region 430 is shown in breakawayview. Furthermore, the distal end of the region just proximal to theflexible region 430 as well as the flexible region 430 has been expandedin scale so that certain details are more clearly visible.

Referring to FIG. 4, the flexible region 430 is affixed to the outertube 406 by a weld 420. The flexible region 430 can also be fixed to theouter tube 406 by a crimp, pin, setscrew, adhesive bond, interferencefit, mechanical interlock, thread, or the like. The attachment betweenthe flexible region 430 and the outer tube 406 is made at the proximalend of the flexible region 430 and a second attachment or weld 420 canbe made at the distal end of the flexible region 430 so as to attach toa length of distal outer tube 406. The flexible region 430 can comprisea length of coiled wire such as that used in guidewires, it can be atube that comprises cutouts to provide a backbone configuration toimpart flexibility, it can be a length of polymeric tube withelastomeric characteristics, or it can be another type of structure thatis known in the art as providing flexibility. These preferred structuresalso advantageously provide column strength and kink resistance to theflexible region 430. The center of the flexible region 430 is hollow andcomprises a lumen, which is operably connected to the central lumen ofthe outer tube 406 at both the proximal and distal end of the flexibleregion 430. The stopcock 110 is affixed, at its distal end, to the outertube hub 414. The outer tube hub 414 further comprises a deflectinglever 416 that is affixed to the axis cylinder 424, which serves as anaxle or rotational pin, and can be moved proximally or distally bymanual action on the part of the operator or by a motor or otherelectromechanical actuator (not shown). The deflecting lever 416 isoperably connected to the proximal ends of the deflecting wires 412. Inan exemplary embodiment, one of the deflecting wires 412 is affixed tothe top of the axis cylinder 424 and the other deflecting wire isaffixed to the bottom of the axis cylinder 424. When the deflectinglever is pulled proximally, for example, the top wire 412 is placedunder tension and the tension on the bottom wire is relieved causingtension to be exerted on the distal end of the punch 400. The deflectingwires 412 are slidably routed through the deflecting wire channels 420within the outer tube 406. The deflecting wires 412 also run through thedeflecting wire channels 420 within the flexible region 430. Thedeflecting wires 412 can also be routed through the internal lumen ofthe outer tube 406 and the flexible region 430.

Referring to FIG. 4, the outer tube hub 414 is affixed to the proximalend of the outer tube 406 by a crimp, pin, setscrew, adhesive bond,interference fit, mechanical interlock, thread, or the like. The innertube 404 is affixed to the distal end of the outer tube 406 by a crimp,pin, setscrew, adhesive bond, interference fit, mechanical interlock,thread, or the like. In another embodiment, the inner tube 404 is routedthroughout the length of the outer tube 406. In this embodiment, theinner tube can comprise grooves (not shown) that serve as deflectingwire channels 420 when the inner tube 404 is inserted inside the outertube 406. Such grooves can also be disposed on the interior surface ofthe outer tube 406, rather than on the exterior surface of the innertube 404. The obturator wire 102 and the attached grasping loop 108 areslidably disposed within the inner lumen of the outer tube 406, or theinner tube 404. The inner tube 404 is gently tapered up to the outertube 406 at the distal end of the outer tube 406 in a transition regionso that a dilator effect can be created during distal advancement of thepunch 400. The distal end of the inner tube 404 can comprise a bevel 132(FIG. 2) or other sharp point for punching through biological tissue.The distal end of the inner tube 404 preferably forms a non-coringneedle or punch that does not excise a tissue sample. The non-coringpunch feature is achieved by keeping the central lumen closed or verysmall. The non-coring punch 400 embodiment can comprise filling thelumen of the inner tube 404 with the obturator or stylet wire 102 toprevent the sharp edge of the inner tube from functioning as a trephine.

FIG. 5 illustrates a side view of the punch assembly 400 wherein thedeflecting lever 416 has been withdrawn proximally causing increasedtension in one of the deflecting wires 412, causing the flexible region430 to bend 422 out of the longitudinal axis. The punch assembly 400further comprises the obturator wire 102, the obturator wire graspingtab 108, the stopcock 110, the deflecting lever 416, an axis cylinder424, the hub 414, the outer tube 406, the inner tube 404, and the bend422.

Referring to FIG. 5, the deflecting lever 416 has been moved proximallyand the axis cylinder 424 causing the top deflecting wire 412 to beplaced in tension while the bottom deflecting wire 412 is relaxed. Thedeflecting wires 412 are affixed at their distal end to the outer tube406 or the inner tube 404 at a point substantially at or beyond thedistal end of the flexible region 420. The distal fixation point (notshown) of the deflecting wires 412 is off-center from the axis of theouter tube 406 or inner tube 404. When uneven tension is created in theopposing deflecting wires 412, the uneven tension on the distal end ofthe punch 400 causes the bendable region 430 to undergo deflection intoa curve or bend 422. Similarly, forward movement of the deflecting lever416 will place the bottom deflecting wire 412 in tension while the upperdeflecting wire 412 will be relaxed, causing the punch 400 to undergo abend in the opposite direction (downward). The deflecting lever 416 canfurther comprise a ratchet and lock, a friction lock, a spring-loadedreturn, or other features to hold position or cause the lever and thebendable region 430 to return to a neutral deflection configuration(substantially straight). The spring nature of the outer tube 406 andthe bendable region 430 can advantageously be used to cause a return toneutral once the deflection force is removed from the deflecting lever416. The stylet or obturator wire 102 can be withdrawn or extended toexpose or protect (respectively) the distal end of the inner tube 404which can be sharpened or blunted. The obturator wire 102 can further beused as the primary punch, especially if the distal tip of the obturatorwire 102 is sharpened. If the obturator wire 102 is used as the primarypunch, the proximal end of the inner tube hub is fitted with aTuohy-Borst or other hemostatic valve to permit the obturator wire 102to remain in place. In this embodiment, sidearms affixed proximal to theproximal end of the punch, and operably connected to the central lumen,serve to permit pressure monitoring and dye contrast injection withoutcompromising hemostasis or air entry into the punch assembly 400.

FIG. 6 illustrates a side view of an adjustable spacer 600interconnecting a guide catheter 620 and a punch assembly 100. Thespacer 600 further comprises a proximal connector 602, a rotating nut604, an inner telescoping tube 608, a threaded region 606, a distallocking connector 610, and an outer telescoping tube 614. The guidecatheter further comprises a tube 622, a hub 624, and a proximalconnector 626. The punch assembly 100 further comprises the stopcock110, the distal rotating locking connector 612, the inner tube pointer112, the outer tube pointer 114, and the inner tube hub 116. The spacer600 can comprise an optional slot 630.

Referring to FIG. 6, the punch assembly 100 is inserted through thecentral lumen of the adjustable spacer 600. The distal end of the punchassembly 100 is then inserted through the central lumen of the guidecatheter 620. The hub 624 of the guide catheter 620 is affixed to theproximal end of the guide catheter tube 622. The distal end of the hub624 comprises a female Luer lock connection, which is bonded to, orintegrally affixed to the hub 624. The hub 624 can further comprise aseal or hemostasis valve such as a Tuohy-Borst fitting. The punch 100hub 116 is terminated at its distal end by a swivel male Luer lockconnector 612. The adjustable spacer 600 comprises an outer telescopingtube 614, shown in partial cutaway view that is terminated at itsproximal end with a female Luer lock 602. The proximal end of the outertelescoping tube 614 has a flange that permits rotational attachment ofthe rotating nut 604, shown in partial cutaway view, so that therotating nut is constrained in position, longitudinally, relative to theouter telescoping tube 614 but is free to rotate. The inner telescopingtube 608 is affixed at its distal end with a swivel male luer connector610, or equivalent. The proximal end of the inner telescoping tube 608is affixed to, or comprises, the integral threaded region 606. Thethreaded region 606 mates with the internal threads on the rotating nut604. As the rotating nut 604 is rotated, either manually or by anelectromechanical device, it moves forward or backward on the innertelescoping tube 608 and threaded region 606 thus changing the spacebetween the hub 116 of the punch 100 and the proximal end of the hub 624of the guide catheter 620. The system is preferably set for spacing thatpre-sets the amount of needle or stylet travel. In an embodiment, therotating nut 604 comprises a quick release that allows disengagement ofthe inner telescoping tube 608 from the outer telescoping tube 614 sothat collapse is permitted facilitating the tissue punching procedure ofadvancing the punch 100 distally relative to the hub 624. The systemfurther comprises hemostatic valves at some, or all, externalconnections to prevent air leaks into the punch 100. The telescopingtube 608 can be set to disengage from the outer telescoping tube 614 toallow for longitudinal collapse so that the punch 100 can be advanceddistally to provide its tissue punching function. In another embodiment,the spacer 600 comprises the slot 630 that permits the spacer to beremoved sideways off the punch 100. The slot 630 is wide enough to allowthe outer tube 106 to fit through the slot 630 so the spacer 600 can bepulled off, or removed from, the punch 100 prior to the punchingoperation. Thus, the slot 630 can be about 0.048 to 0.060 inches wideand extend the full length of the spacer 600. With the slot 630, thespacer 600 comprises a generally “C-shaped” lateral cross-section. Thespacer 600 can further comprise a slot closure device (not shown) toprevent inadvertent removal of the punch 100.

In another embodiment, the threaded region 606 and the rotating nut 604are replaced by a friction lock on telescoping tubes, a ratchet lock, orother suitable distance locking mechanism. In yet another embodiment, ascale or series of markings (not shown) is incorporated into theadjustable spacer 600 to display the exact distance between the proximalend and the distal end of the spacer 600. In another embodiment, theproximal end and the distal end of the spacer 600 do not comprise one orboth of the female Luer lock 602 or the rotating male Luer lock 610. Inthis embodiment, the spacer 600 provides positional spacing but does notaffix the punch 100 to the guide catheter 620 so that the two devicesmove longitudinally as a unit. In another embodiment, the pull wires 412of FIG. 4, which are strong in tension, but cannot support compression,are replaced by one or more control rods, which are flexible but whichhave column strength. Thus, deflection can be generated by impartingeither tension on the control rod or compression and such tension andcompression is capable of deflecting the distal tip of the punch 400without the need of a separate control rod to impart tension in theother direction. The inner tube hub 116 is terminated at its proximalend by a female Luer, Luer lock, threaded adapter, bayonet mount, orother quick release connector. The quick connect or female Luer can bereleasably affixed to a hemostasis valve, other stopcock, pressuretransducer system, “Y” or “T” connector for pressure and radiopaquecontrast media infusion, or the like.

In another embodiment, a vacuum line can be connected to a port affixedto the proximal end of the punch. The port can be operably connected toa bell, cone, or other structure at the distal end of the punch by wayof a lumen, such as the central lumen of the inner tube or an annulusbetween the intermediate and outer tube, within the punch. Byapplication of a vacuum at the proximal end of the punch, the distalstructure can be releasably secured to the atrial septum prior topunching through. In another embodiment, a corkscrew structure projectsout the distal end of the punch and is operably connected to a knob orcontrol at the proximal end of the punch by way of a control rodslidably or rotationally free to move within a lumen of the punch. Thecorkscrew structure can be screwed into tissue to releasably secure thedistal end of the punch to the tissue, for example, to enhance stabilityof the punch prior to, during, or after the punching operation.

Referring to FIG. 1, in another embodiment, the inner tube 104, theouter tube 106, or both, are fabricated from shape memory nitinol. Inthis embodiment, electrical energy can be applied to the pre-bentregions of the inner tube 104, the outer tube 106, or both. Uponapplication of electrical energy, Ohmic or resistive heating occurs,causing temperature of the tubes to increase. The nitinol changes itsstate from martensitic to austenitic, with the increase in temperature,and can assume a pre-determined configuration or stress state, which isin this case curved. The austenite finish temperature for such aconfiguration is approximately 40 degrees centigrade or just above bodytemperature. In yet another embodiment, the austenitic finishtemperature can be adjusted to be approximately 28 to 32 degreescentigrade. The punch 100 can be maintained at room temperature where itis substantially martensitic and non-rigid. Upon exposure to bodytemperatures when it is inserted into the core lumen of the guidecatheter, it will assume its austenitic shape since body temperature isaround 37 degrees centigrade. This can cause the punch 100 to curve fromsubstantially straight to substantially curved. In this configuration,only a single tube, either the inner tube 104 or the outer tube 106 isnecessary, but both tubes, while potentially beneficial, are notrequired.

FIG. 7A illustrates a side view, in partial breakaway, of the distal endof an axially elongate outer tube 710, comprising a lumen 714, aproximal, uncut portion 712, a plurality of lateral partial cuts 716,and a plurality of longitudinal “T” cuts 718, according to anembodiment.

Referring to FIG. 7A, the outer tube 710 serves as the outer tube of anarticulating septal punch such as that illustrated in FIG. 5. Theplurality of partial lateral cuts 716 serve to render the region of theouter tube 710 in which the lateral cuts 716 are located more flexiblethan the proximal region 712. The plurality of longitudinal “T” cuts,serve to further render the region of the outer tube 710, in which the“T” cuts 718 reside, more flexible than in tubes where such “T” cuts 718were not present. The longitudinal “T” cuts 718 are optional but arebeneficial in increasing the flexibility of the outer tube 710 in theselected bend region. The partial lateral slots 716 can be spaced apartby about 0.02 to about 1.0 inches with a preferred range of about 0.1inches to about 0.8 inches and a further preferred range of about 0.15inches to about 0.5 inches. In an exemplary embodiment, the partiallateral slots 716 are spaced about 0.17 inches apart. The spacingbetween the partial lateral slots 716 can vary. In some embodiments, forexample, the spacing between the partial lateral slots toward theproximal end of the outer tube 710 can be about 0.3 inches while thosepartial lateral slots 716 nearer the distal end of the outer tube 710can be spaced about 0.15 inches apart. The spacing can change in a stepfunction, it can change gradually moving from one end of the outer tube710 to the other, or it can increase and decrease one or more times togenerate certain specific flexibility characteristics. Increased spacingincreases the minimum radius of curvature achievable by compression ofthe partial lateral slots 716 while decreased spacing allows for asmaller minimum radius of curvature.

The number of lateral cuts 716 or, optionally, the number of lateralcuts 716 with T-cuts 718 can number between about four and about 50 witha preferred number being between about six and about 25 and a morepreferred number of about eight to about fifteen. In the illustratedembodiment, there are 12 partial lateral cuts 716, each modified with a“T” slot 718. In other embodiments, the partial lateral cuts 716 can beshaped differently. For example, the partial lateral cuts 716 can be atangles other than 90 degrees to the longitudinal axis, curved, V-shaped,Z-shaped, W-shaped or the like. In other embodiments, the ‘T’ slots 718can have, for example, further cuts approximately lateral to thelongitudinal axis, along any portion of the “T” cut 718. Thisconstruction provides the outer tube with a flexible region at itsdistal end. The flexible region is a region at the distal end of theouter tube that is significantly more flexible and susceptible todeflection than the remaining proximal region of the outer tube.

The outer tube 710 can have an outer diameter of about 0.020 to about0.1 inches with a preferred outside diameter of about 0.040 to about0.060 inches and a more preferred diameter of about 0.045 inches toabout 0.055 inches. In the illustrated embodiment, the outside diameteris about 0.048 inches while the inner diameter is about 0.036 inches.The inside diameter of the outer tube 710 can range from about 0.010inches to about 0.090 inches.

FIG. 7B illustrates an embodiment of a side view, in partial breakaway,of the distal end of an axially elongate inner tube 720, comprising alumen 724, a proximal, uncut portion 722, a longitudinal slot 726further comprising an angled lead in 728, a free side 734, a pusher orconnected side 732, and a distal tip 730.

Referring to FIG. 7B, the distal tip 730 interconnects the free side 734and the pusher side 732. The distal tip 730 further comprises a tapereddistal end that can be beveled or otherwise shaped into a sharp edgesuch as by circumferentially forming a trephine-like (cylindrical) bladeor even a pointed end that is closed or partially closed. The free side734 and the pusher side 732 are generally integrally formed but can alsobe affixed to each other by welding, adhesives, fasteners, or the like.

The lead in 728 to the longitudinal slot 726 is beneficially angled toprevent guidewires, stylets, or other catheters, which are insertedthrough the central lumen 724 from being caught or bumping against anedge. The angled lead in 728 serves a guide to assist with traverse of astylet, obturator, or guidewire past the lead in 728 and into the distalregion of the steerable transseptal needle. The lead in 728 can beangled from between about −80 degrees (the angle can be retrograde) fromthe longitudinal axis (fully lateral) to about +2 degrees and preferablyfrom about +5 degrees to about +20 degrees with a most preferred angleof about +8 degrees and about +15 degrees. In the illustratedembodiment, the angle of the lead in slot 728 is about 10 degrees fromthe longitudinal axis. A second feature of the lead in 728 is that it bepositioned or located proximally to the most proximal “T” slot 718 inthe outer tube 710 when the two tubes 710, 720 are affixed to each other(see FIG. 9). The lead in 728 is located at least 1-cm proximal to theproximal most “T” slot 718 and preferably at least 2-cm proximal to theproximal most “T” slot 718 so that bending in the distal region does notdistort the lead in 728 and cause kinking, misalignment, or pinching ofthe internal lumen 724.

The inner or inner tube 720 can have an outside diameter that isslightly smaller than the inside diameter of the outer tube 710 so thatthe inner tube 720 can be constrained to move longitudinally or axiallywithin the outer tube 710 in a smooth fashion with relatively littleforce exerted. In the illustrated embodiment, the outside diameter ofthe inner tube 720 is about 0.033 inches giving about a 0.0015 inchradial clearance between the two tubes 710 and 720. The inside diameterof the inner tube 720 can range from about 0.002 to about 0.015 inchesless than the outside diameter of the inner tube 720. In the illustratedembodiment, the wall thickness of the inner tube is about 0.006 inchesso the inside diameter of the inner tube is about 0.021 inches. Thelumen 724 of the inner tube 720 can be sized to slidably accept a styletor obturator 140 such as illustrated in FIGS. 1 and 2. A typical styletwire 140 can range in diameter from about 0.01 to about 0.23 inches witha preferred diameter range of about 0.012 to about 0.020 inches. Inanother embodiment, the outer tube 710 has an outside diameter of about0.050 inches and an inside diameter of about 0.038 inches. In thisembodiment, the inner tube 720 has an outside diameter of about 0.036inches and an inside diameter of about 0.023 inches. The radial wallclearance between the inner tube 710 and the outer tube 720 is about0.001 inches and the diametric clearance is about 0.002 inches. Theannulus between the two tubes must be substantially smooth, free fromburrs, and free from contamination because the two tubes 710, 720beneficially need to translate along their longitudinal axis relative toeach other over relatively long axial distances of about 50 to about150-cm.

The inner tube 720 transmits force along its proximal non-slotted region722 from the proximal end of the inner tube 720 to the lead in 728 wherethe force continues to be propagated along the connected side 732 to thedistal end 730. The outer tube 710 transmits force along its proximalnon-slotted region 712. Longitudinal forces applied to the distal,flexible region with the slots 716 cause deformation of the outer tubein an asymmetrical fashion with the side of the outer tube 710comprising the partial lateral slots 716 forming an outer curve if theslots 716 are expanded and an inside curve if the slots 716 arecompressed. Forces to cause bending are preferably exerted such that thepartial lateral slots 716 are compressed up to the point where the gapcloses, but no further, however forces can also be exerted to expand theslots 716, however limits on curvature are not in place because thelateral slots 716 can open in an unrestrained fashion except for thematerial properties of the outer tube 710.

The disconnected side 734 of the inner tube 720, separated from theconnected side 732 by the longitudinal slot 726 and the lead in 728,serves to maintain an undistorted tube geometry and provide resistanceto deformation while helping to maintain the inner lumen 724 in a roundconfiguration and provide a shoehorn or funnel effect to guide anobturator, guidewire, or stylet 140 therethrough as they are advanceddistally. The disconnected side 734, being separated from the forcetransmitting member 722 cannot provide any substantial longitudinal loadbearing structure, although at its distal end, where it is integral oraffixed to the distal end 730, some tension load carrying capabilityexists. The inner tube 720 can be considered a split tube and does notcarry a load in compression or tension along substantially the entirelength of the disconnected side 734.

The partial lateral slot 716 in the inner, or intermediate, tube 720 andthe T-Slot 718 in the outer tube 710, as well as the longitudinal slot726 in the inner or inner tube 720, and the lead in slot 728 can befabricated by methods such as, but not limited to, electron dischargemachining (EDM), wire EDM, photoetching, etching, laser cutting,conventional milling, or the like. In other embodiments, different slotconfigurations can also be employed, such as curved slots, complexslots, zig-zag slots, or the like. In some embodiments, the partiallateral slot 716 can be configured with a tongue and groove or dovetaildesign to prevent or minimize lateral movement or torqueing of the outertube 710 in the flexible region. In some embodiments, the tongue andgroove or dovetail (not shown) can be generally centered between two “T”slots, for example. The parts can be ganged and fixture such that, usingwire EDM, for example, a plurality of tubes can be cut to reducemanufacturing costs. As many as 20 to 30 tubes, or more, can befixtured, secured, and etched by the aforementioned methods.

FIG. 8 illustrates a side, cross-sectional view of an embodiment of ahub end 800 of an articulating septal punch. The hub end 800 comprisesthe outer tube 710, the inner tube 720, a hub body 802, a stopcockpetcock 804 further comprising a petcock handle 808 and a petcockthrough bore 806, a Luer lock fitting 812, an arrow pointer 810, a keyedlumen 834, a setscrew or pin 820, a jackscrew body 816 furthercomprising a plurality of threads 828 and a central lumen 832, a controlknob 814 further comprising a plurality of threads 818, a central lumen830, the protrusion 838, and a circumferential recess 822, an outer tubeweld 824, an orientation mark 840, and an inner tube weld 826. The hubbody 802 can further comprise a plurality of recesses or complementarystructures 836.

Referring to FIG. 8, the petcock 804 is affixed to the petcock handle808 by welding, integral fabrication, fasteners, adhesives, or the like.The petcock 804 is retained within a lateral through bore in the hubbody 802, which is in the illustrated embodiment, tapered, using alocking “C” washer, fastener, screw, pin, or the like (not shown). Thepetcock 804 can be rotated about its longitudinal axis to align thethrough bore 806 with the axis and central lumen of the hub body 802 orit can be rotated sideways to shut off and seal the lumen against theflow of fluids. The Luer lock 812 can be affixed to, or integrallyfabricated with, the hub body 802. The knob 814 is retained within thehub body 802 by the setscrew of pin 820 which prevents axial movementbut permits rotational movement as constrained by the setscrew,projection, or pin 820 riding within the circumferential recess 822which is integrally formed or affixed to the knob 814. The jackscrewbody 816 is capable of axial movement within the hub body 802 but isrestrained from rotation about the long axis by flats or features on theexterior of the jackscrew body 816 which are constrained by flats orfeatures in the keyed lumen 834. The knob 814 comprises threads 828 onits internal lumen which engage with external threads 818 on thejackscrew body 816. Rotation of the knob 814 thus causes the jackscrewbody 816 to move axially proximally or distally with mechanicaladvantage. Rotation of the knob 814 can be forced using manual action orusing a motor or other mechanism (not shown). The outer tube 710 isaffixed to the jackscrew body 816 by the outer tube weld 824. The innertube 720 (which can also be called the inner tube) is affixed to the hubbody 802 by the inner tube weld 826. The central lumen 724 of the innertube 720 is operably connected to a central lumen of the hub body 802,the petcock through bore 806, and the lumen of the Luer fitting 812.

The knob 814 can comprise markings 840 to permit the user to visualizeits rotary or circumferential position with respect to the hub body 802.These markings 840 can comprise structures such as, but not limited to,printed alphanumeric characters (not shown), a plurality of geometricshapes such as dots, squares, or the like, or the markings can compriseraised or depressed (embossed) characters of similar configuration asdescribed for the printed markings. In an embodiment, the knob 814 cancomprise a number on each of the facets so the facets can be numberedfrom one to 6, in the illustrated embodiment. The knob markings 840 canfurther comprise raised structures, as illustrated, which can further beenhanced with contrasting colors for easy visualization.

The knob 814 can further comprise one or more complementary structuresaffixed or integral thereto, such as a plurality of protrusions 838 thatfit into detents 836 affixed or integral to the proximal end of the hubbody 802. Such protrusions extending into detents in the hub body 802can provide a ratcheting or clicking sound as well as providingresistance to inadvertent movement of the knob 814 once it is rotated tothe correct location. The knob 814, in some embodiments, can be biasedtoward the hub body 802 to ensure that complementary structures such asthe protrusions and detents come into correct contact. In otherembodiments, the knob 814 can comprise a ratchet system to furthercontrol its rotary movement with respect to the hub body 802. In otherembodiments, the knob 814 can comprise one or more detents (not shown)while the hub body 802 can comprise one or more complementaryprotrusions (not shown). It is beneficial that the knob 814 be movedonly when required by the user and not by accident or not when it isrequired to maintain its rotary position and, by consequence, thecurvature at the distal end of the tubing. The number of ratchetlocations, or low energy positions or set points, can range from about 2per 360 degree rotation to about 20 with a preferred number of ratchetlocations ranging from about 4 to about 12.

The hub body 802 can be fabricated from biocompatible metals such as,but not limited to, stainless steel, titanium, nickel coated brass,cobalt nickel alloy, and the like, although it could also be fabricatedfrom polymeric materials in a less expensive format. The knob 814 can befabricated from the same metals as the hub body 802 but it canbeneficially be fabricated from biocompatible polymers such as, but notlimited to, polyamide, polyimide, polyvinyl chloride (PVC),acrylonitrile butadiene styrene (ABS), acetyl polymers, polycarbonate,polysulfone, PEEK, Hytrel®, Pebax®, and the like. The petcock 804 andpetcock handle 808 can be fabricated from the same materials as the knob814, or it can be different materials. The jackscrew body 816 can befabricated from the same materials as the hub body 802, or fromdifferent materials, but must be able to be strongly affixed to theouter tube 710.

FIG. 9 illustrates a side view, in partial breakaway, of an embodimentof a distal end 900 of an articulating trans-septal punch with anystylets removed. The distal end 900 comprises the outer tube 710 furthercomprising the lateral partial slits 716 and the intermediate (or inner)tubing 720 further comprising the longitudinal slit 726 and the distaltip 730. A weld 902 affixes the distal end of the outer tube 710 to theconnected side 732 of the inner tube. The distal end 900 can furthercomprise one or more separate radiopaque markers 904.

Referring to FIG. 9, outer tube 710 and the inner tube 720 are rotatedabout the longitudinal axis such that the connected side 732 of theinner tube 720 is generally aligned with, and affixed or welded 902 to,the outer tube 710 on the side comprising the partial lateral slits 716.The width of the partial lateral slits 716, the T-slots 718, and thelongitudinal slot 726 can range from about 0.001 to about 0.050 incheswith a preferred range of about 0.005 to about 0.020 inches. In theillustrated embodiment, the slits 716, 718, and 726 are about 0.010inches. The width of the partial lateral slits 716 on the outer tube 710can be used, in compression to provide at least some limit to how muchthe outer tube 710 can bend in compression along the side comprising thepartial lateral slits 716. Note that the inner tube 720 extends beyondthe distal end of the outer tube 710. In the illustrated embodiment, theinner tube 720 extends about 10 mm to about 20 mm beyond the distal endof the outer tube 710. This construction provides for reduced devicecomplexity, increased reliability of operation, and reducedmanufacturing costs relative to other steerable devices. The system alsoprovides for high stiffness when the distal end 900 is straight, asillustrated, curved as in FIG. 11, or curved, bent, deflected, steered,or otherwise deformed in any configuration between straight andmaximally curved. The articulating trans-septal punch is necessarilystiff, has high column strength, and has significant resistance tobending from external sources because it needs to force an incisionthrough tissue at the end of a very long, 2 to 4 foot length, of verysmall diameter punch tubing. Thus, the all-metal tubing punch cantranslate forces from its proximal end to its distal end that apolymeric catheter could not come close to equaling. Catheters carryingsuch a punch would be less effective for the specific purpose oftransseptal puncturing than would the articulating trans-septal needle.

The distal end 900 of the articulating trans-septal punch is generallyfabricated from metals with sufficient radiopacity or radio-densenessthat they are clearly visible under fluoroscopic or X-ray imaging.However, if this is not the case, additional radiopaque markers 904 canbe affixed to the outer tube 710, the inner tube 720, or both. Theseradiopaque markers can comprise materials such as, but not limited to,tantalum, gold, platinum, platinum iridium, barium or bismuth compounds,or the like.

Close tolerances between the internal diameter of the outer tube 710 andthe outside diameter of the inner tube 720, ranging from a radial gap ofbetween about 0.0005 inches to about 0.008 inches, depending on diametercause the two tubes 710 and 720 to work together to remain substantiallyround in cross-section and not be ovalized, bent, kinked, or otherwisedeformed. This is especially important in the flexible distal regioncomprising the partial lateral cuts 716 on the outer tube 710 and thelongitudinal slot 726 in the inner or inner tube 720. The two tubes 710and 720 can be fabricated from the same materials or the materials canbe different for each tube 710, 720. Materials suitable for tubefabrication include, but are not limited to, stainless steel, nitinol,cobalt nickel alloy, titanium, and the like. Certain very stiff polymersmay also be suitable for fabricating the tubes 710, 720 including, butnot limited to, polyester, polyimide, polyamide, polyether ether ketone(PEEK), and the like. The relationship between the inner tube 720, theouter tube 710, and the slots 716, 718, 726, 728 serve to allowflexibility and shaping in high modulus materials such as those listedabove, which are not normally suitable for flexibility. The internal andexternal surface finishes on these tubes 710, 720 are preferablypolished or very smooth to reduce sliding friction between the two tubes710, 720 because of their very small cross-sections and their relativelylong lengths. Lubricants such as, but not limited to, silicone oil,hydrophilic hydrogels, hydrophilic polyurethane materials, PFA, FEP, orpolytetrafluoroethylene (PTFE) coatings can be applied to the innerdiameter of the outer tube 710, the outer diameter of the inner tube720, or both, to decrease sliding friction to facilitate longitudinalrelative travel between the two tubes which is necessary forarticulating the flexible, slotted region near the distal end 900 of thearticulating transseptal sheath. The exterior surface of the outer tube710 can be covered with a polymeric layer, either substantiallyelastomeric or not, which can cover the slots 716, 718, etc. and presenta smoother exterior surface to the environment. The exterior surface canbe affixed or configured to slip or slide over the exterior of the outertube 710.

The weld 902 affixes the outer tube 710 to the intermediate or innertube 720 such that they cannot move relative to each other along thelongitudinal axis at that point. However, since the two tubes 710, 720are affixed to each other on the side of the outer tube 710 containingthe partial lateral slots or gaps 716, compression or expansion of thosegaps 716 can be accomplished by moving the weld 902 by relative movementof the inner tube 720 and the outer tube 710. The weld transmits theforce being carried by the connected side 732 of the inner or inner tube720 to the slotted side of the outer tube 710. Note that the terms innertube 720 and inner tube 720 are used interchangeably, by definition. Theinner tube 720 becomes an inner tube 720 if another tube or catheter ispassed through its internal lumen 724.

In other embodiments, since the inner or inner tube 720 is split 726lengthwise in the flexible region, a portion, or the entirety, of thedistal end of the inner tube 720 can be affixed, adhered, welded,fastened, or otherwise attached to the outer tube 710 and functionalitycan be retained. The distal end 730 of the inner tube 720 can, in someembodiments be retained so as to create a cylindrical distal region 730in the inner tube 720 and this entire cylindrical distal region 730, ora portion thereof that does not project distally of the distal end ofthe outer tube 710 can be welded to the outer tube 710 around a portion,or the entirety of the circumference of the outer tube 710. If only aportion of the inner tube 720 is welded to the outer tube 710, then theweld is beneficially located, approximately centered, on the side of theouter tube 710 comprising the partial lateral slots 716. The cylindricaldistal region 730 is a beneficial construction, rather than completelycutting the inner tube 720 away on one side, since the distal region 730projects distally of the distal end of the outer tube 710 to form thetip of the punch further comprising a sharpened tip 1102, 1302configured to punch through myocardial tissue (refer to FIGS. 11 and13).

In some embodiments, one of the welds, all of the welds, or a portion ofthe welds can be completed using techniques such as, but not limited to,TIG welding, laser welding, silver soldering, fasteners, adhesives,plasma welding, resistance welding, interlocking members, or acombination thereof. Laser welding is beneficial because it is highlyfocused and can be located with high accuracy. These welds include theweld 902 at the distal end that connects the inner tube 720 and theouter tube 710 as well as the welds at the proximal end connecting theinner tube 720 to the hub and the outer tube 710 to the traveler of thejack-screw 816.

FIG. 10 illustrates an oblique external view of an embodiment of theproximal end 800 of the steerable trans-septal needle comprising theouter tube 710, the knob 814, the hub body 802, the arrow pointer 810further comprising the pointed end 1004, a stopcock body 1006, thepetcock 804, the petcock handle 808, and the Luer fitting 812 furthercomprising a locking flange 1002.

Referring to FIG. 10, the pointed end 1004 can be integrally formed withthe arrow pointer 810, or it can be affixed thereto. The arrow pointer810 can be integrally formed with the hub body 802, or it can be affixedthereto using fasteners, welds, adhesives, brazing, soldering, or thelike. The stopcock body 1006 can be integrally formed with the hub body802 or it can be affixed thereto using fasteners, welding, soldering,brazing, adhesives, threads, bayonet mounts, or the like. Referring toFIGS. 8 and 10, the lumen of the Luer fitting 812 is operably connectedto the through bore of the petcock 804 if the petcock 804 is alignedtherewith (as illustrated), or the petcock 804 can be rotated about anaxis to misalign the through bore of the petcock 804 with the Luerfitting 812 and prevent fluid flow or passage of solid materialtherethrough. The knob 814 can be round, shaped as a lever, it cancomprise knurls, facets (as illustrated), or it can comprise a pluralityof projections which facilitate grabbing and rotation by the user.Circumferential motion of the knob 814 about is longitudinal axis ispreferably and beneficially smooth but with sufficient friction tomaintain its position in any desired configuration.

FIG. 11 illustrates an embodiment of the distal end 900 of thearticulating trans-septal needle in a curved configuration. The distalend 900 comprises the outer tube 710, the inner tube 720, the outer tubelumen 714, the distal end of the proximal region of outer tube 712, thedistal end 730 of the inner tube 720 further comprising the sharpeneddistal tip 1102, the plurality of outer tube longitudinal cuts or slots718, and the plurality of outer tube partial lateral cuts 716.

Referring to FIG. 11, the outer tube partial lateral cuts 716 representspaces that close up when the side of the tube in which the lateral cuts716 are located is placed in compression. Such compression is generatedby pushing the outer tube 710 distally relative to the inner tube 720.When the partial lateral cuts 716 gaps close, further compression ismuch more difficult because the outer tube 710 stiffens substantiallywhen no further gap exists for compression. The composite structure,with the inner tube 720 nested concentrically inside the outer tube 710is relatively stiff and resistant to kinking no matter what amount ofcurvature is being generated. Such stiffness is essential when using thearticulating trans-septal needle to bend or steer another catheter suchas a Mullins introducer, or other guide catheter.

Preferred radius of curvatures for the distal end can range from about 1inch to about 6 inches, with a preferred range of about 2 inches toabout 4 inches and a more preferred range of about 2.5 to about 3.5inches for the purpose of puncturing the atrial septum. Even smallerradius of curvatures would be appropriate in, for example, thecerebrovasculature, the arteries of the heart, and the like. The radiusof curvature need not be constant. In some embodiments, the proximal endof the flexible region can have the partial lateral cuts spaced morewidely than those at the distal end of the flexible region, causing thedistal end to bend into a tighter radius than, the proximal end of theflexible region. In other embodiments, the distal region can be lessflexible than the proximal end of the flexible region.

The partial lateral cuts 716, and the “T”-slots in the outer tube 710are beneficially treated using etching, electropolishing, passivation,sanding, deburring, machining, or other process to round the externaledges of the partial lateral cuts 716. Thus, the edges are blunted orrounded so they are not sharp such as to cause the articulatingtrans-septal needle to dig, skive, or shave material from the inside ofa polymer guide catheter since that is a primary benefit of using thearticulating trans-septal needle rather than a pre-curved,non-articulating, trans-septal needle or other punch that, when advanceddistally through a polymeric sheath, can scrape or skive material fromthe inner diameter of the sheath or introducer.

The distal end 1102 can be sharp in some embodiments but it can also besomewhat or completely blunted. In the case of partially or completelyblunted distal construction, the distal end can be operably connected toa source of electrical or radiofrequency (RF) energy and puncture holescan be created using the electrical or RF energy. The energy is carriedby the inner tube 720, which is preferably electrically insulated fromthe outer tube 710, from the hub 900 into which electrical or RF energycan be applied to the distal tip 1102.

FIG. 12A illustrates a top view of another embodiment of an outer tube1200 in the region of the distal, flexible section, wherein the outertube 1200 comprises a plurality of partial lateral cuts or slots 1206further comprising a dovetail 1202. The dovetail 1202 creates a groove1202 and further comprises a peg or projection 1204 that rides or iscircumferentially constrained within the groove 1202 as long as theouter tube 1200 is neutrally forced, or forced in compression on theside of the partial lateral cuts or slots 1206. The projection 1204riding within the dovetail groove 1202 provides for torque resistanceand torsional rigidity in the area of the dovetail 1202.

FIG. 12B illustrates a side view of the outer tube 1200 in the region ofthe distal, flexible section, wherein the outer tube 1200 comprises thepartial lateral slots 1206, the dovetail 1202 further comprising theprojection 1204, and the “T” slots 718. The T-slots 718 are optional orthey can be configured differently.

The punch can be used to create holes in various structures in the body.It is primarily configured to serve as an articulating or variabledeflection Brockenbrough needle. However, the steerable punch can beused for applications such as transluminal vessel anastomosis, biopsyretrieval, or creation of holes in hollow organs or lumen walls. Thepunch can be used in the cardiovascular system, the pulmonary system,the gastrointestinal system, or any other system comprising tubularlumens, where minimally invasive access is beneficial. The punch can beconfigured to be coring or non-coring in operation, depending on theshape of the distal end and whether an obturator or the circular hollowend of the punch is used to perform the punching operation. In thecoring configuration, a plug of tissue is removed using, for example, acylindrical cutting blade at the distal end while in the non-coringconfiguration, substantially no tissue is removed from the patient. Thepunch facilitates completion of transseptal procedures, simplifiesrouting of the catheters, minimizes the chance of embolic debris beingdislodged into the patient, and improves the ability of the cardiologistto orient the punch for completion of the procedure. The punch of thepresent invention is integral and steerable. It is configured to be usedwith other catheters that may or may not be steerable, but the punchdisclosed herein does not require external steerable catheters orcatheters with steerability to be steerable as it is steerable orarticulating on its own. The punch is capable of bending and unbending apractically unlimited number of times. The punch is especially usefulwith catheters that are not steerable since the punch comprises its ownsteering system.

The punch can be removed from the lumen of a catheter after it completesperforation of the hollow organ or vessel wall, through which it isplaced, so as to maximize the size of said lumen and allow foradvancement of devices such as diagnostic mapping catheters, ablationcatheters, catheters to place atrial appendage closure devices, mitralvalve repair devices, mitral valve replacement devices, annuloplastyrings, and the like. Without removal of the punch, the lumen iscompromised and the capacity of the sheath to introduce catheters isreduced, given a certain outside diameter. Minimizing the outsidediameter of the sheath is important in preventing a damaged fossaOvalis. This device is intended for use with catheters and is notintended for use as integral to a catheter. This device steers itselfand can steer a catheter but is not a replacement for a steerablecatheter. For instance, an introduction sheath or guide catheter can besteered and bendable but if the trans-septal punch is not steerable andis pre-bent, advancement of the pre-bent trans-septal punch through thesheath or guide catheter and its obturator, steerable or not, will causethe sharp distal end of the trans-septal punch to shave or skive offdebris or material from the inside diameter of the obturator of thesheath or guide catheter or the catheters themselves. This shaving orskiving can occur even when the trans-septal punch is protected by acentral obturator, stylet, inner tube, or guidewire. Use of a steerableobturator does not help the situation because a pre-bent, trans-septalpunch, advanced through a straight, steerable obturator will still shaveoff or skive material from the inside diameter of the obturator.

The steering mechanism disclosed herein in FIGS. 7A & 7B through-FIG. 11can be used to steer other types of catheters, guide catheters,introducers, sheaths, guidewires, or even obturators that are placedwithin the aforementioned devices, with high degree of control over longlengths up to 250 cm or more while requiring less wall thickness andthus allowing for larger internal lumens than steerable devices of theprior art with the same outside diameter. Typical sheaths can haveinternal lumens with capacities of, for example, 6-Fr to 12-Fr and stillmaintain very thin walls of around 1-Fr. While smaller catheters orguide catheters with lumens in the range of about 2-Fr to 5-Fr can haveeven smaller wall thicknesses, depending on the materials used toconstruct the walls of the sheath. Some sheath constructions cancomprise composite materials such as an inner tube fabricated from metaland an outer tube fabricated from metal with a polymeric exteriorcoating. The inner tube can further be coated with an interior liner of,for example PTFE, or other fluoropolymers (PFA, FEP), Parylene, Pebax®,Hytrel®, polyimide, polyamide, PET, or the like, to create certainreduced frictional properties, electrically insulating properties, orboth. These coatings or liners can range in thickness from about 0.0001to about 0.005 inches, with a preferred thickness range of about 0.0005to 0.002 inches. Electrical insulating properties are important ifelectrically conductive catheters are inserted through one or morelumens of a guide catheter or introducer whose mechanical properties arederived from high strength materials such as, in certain embodiments,conductive metal. Electrical insulating properties are also importantshould the device itself be used for electrical purposes such as, butnot limited to, RF Ablation, RF hole puncturing, RF coagulation, and thelike.

The steering mechanism disclosed herein, comprising two or more nestedaxially elongate cylindrical tubes moving relative to each other onlyalong the longitudinal axis, can provide a high degree of precision,repeatability, force, column strength, torsional control, and the like,in a configuration with extremely thin walls and large inside diameter(ID) to outside diameter (OD) ratio. One of the tubes comprises partiallateral cuts or complex lateral gaps and the other tube comprising asplit running substantially the length of the flexible region. Thedisconnected side of the slit tube can be removed so that only apartially formed, connected side remains. However, in preferredembodiments, the disconnected side, which is actually retained at thedistal end, is not removed but serves to fill space within the lumen ofthe outer tube 710 to prevent kinking, improve column strength, preventlumen collapse and provide for guiding of central stylets or catheters.Prior art devices require greater wall thickness, which reduces the sizeof the internal lumen relative to a given outside diameter, or they donot have the same degree of precise movement at the distal tip undercontrol from the proximal end of the device.

FIG. 13 illustrates a side view of the distal end 900 of an articulatingtransseptal punch advanced through a central lumen 1312 of a dilator orobturator 1310 of a guide catheter 1314. The articulating transseptalpunch distal end 900 comprises the outer tube 710, comprising theplurality of partial lateral cuts 716, and the inner tube 720,comprising a sharpened distal tip 1302. The sharpened distal tip 1302comprises a bevel 1304, one or more facets 1308, a point 1318, and arounded or blunted outside edge 1306. The obturator 1300 furthercomprises the central lumen 1312. The guide catheter 1314 furthercomprises a central lumen 1316.

Referring to FIG. 13, the guide catheter 1314 and its obturator 1310 aregenerally curved near the distal end. When the distal end 900 isadvanced distally through the lumen 1312 of the obturator 1310, scrapingof the inner wall of the obturator 1310 is prevented by inclusion of arounded edge 1306 of the distal end 1302 toward the outside of thecurvature. The distal sharp end 1302 comprises a bevel 1304 to create asharpened tissue punch with a point 1318. The facets 1308 are optionalbut can be provided in numbers ranging from one to about 10. The bevel1304 can be generated at a single angle, or with a complex curvature. Insome embodiments, the bevel 1304 can be generated at an angle of about20 to about 80 degrees from lateral to the axis of the tube with apreferred range of about 30 to about 60 degrees from lateral, and a mostpreferred range of about 40 to about 50 degrees. The point 1318 can be apoint in three dimensions or in two dimensions, such as the point 1318illustrated herein.

FIG. 14 illustrates the distal end 900 of an articulating transseptalpunch further comprising a stylet 1400. The stylet comprises the corewire 1402, the proximal lock 1404 (not shown), a collapsing shield 1408,and the rounded distal tip 1406.

Referring to FIGS. 13 and 14, the stylet 1400 is slidably and removablyinserted through the central lumen of the inner tube 720 to assist withblunting the sharpened distal end. Stylets sufficiently small to fitthrough these central lumens of the inner tube 720 are generally quitesmall, having a diameter of about 0.012 to 0.015 inches and arenecessarily very weak. They are subject to bending and kinking andcannot hide a sufficient amount of the distal pointed end 1302 toprevent damage to the inside of a polymeric guide catheter 1314 or itsobturator 1310. Because the inner tube 720 has a very thick wallrelative to its overall diameter, a wire inserted through the centrallumen of the inner tube 720 cannot protect or shield the distal end 1302adequately. Thus, a regular stylet 1400 is only partially useful inpreventing skiving material from the inside of the guide catheter 1314or obturator 1310 unless it includes the collapsing shield 1408. Aradially collapsing feature 1408 of the obturator 1400 can be beneficialin protecting the distal end with more completeness than anon-collapsing version. The collapsing feature 1408 is collapsedradially, laterally, or diametrically by withdrawing the obturator 1400inside the inner tube 720 and it expands on its own using self-expansionunder spring bias, shape memory recovery, or the like. The obturator1400 can be fabricated from materials such as, but not limited to,stainless steel, nitinol, cobalt nickel alloy, titanium, and the likeusing methods such as cold rolling or tempering to achieve substantialspring conditions. In the illustrated embodiment, the collapsing shieldfeature 1408 is created by means of a split tube of spring stainlesssteel, comprising a plurality of slots or openings 1410 which are biasedoutward to create a bulge when unrestrained. The slotted tube shield1408 is integral or affixed to the core wire 1402. The amount of outwardbulge of the shield 1408 is not large but is sufficient to substantiallyequal or exceed the wall thickness of the inner tube 720.

In some embodiments, the outer tube 710 can be modified to adjuststiffness. It can be preferential to increase the resistance to bendingmoving distally to proximally on the outer tube 710. This increase inbending resistance contravenes the tendency of the outer tube to bendmore severely at the proximal end of the flexible region than in thedistal region. It is possible to configure the bending so that the bendradius is approximately constant or such that a greater curvature(smaller radius of bending) is generated moving toward the distal end ofthe bendable region. The partial lateral slots 716 can be cut withreduced depth more proximally to increase the resistance to bendingimparted by the outer tube 710. The partial lateral slots 716 can be cutmore narrowly in the more proximal regions to reduce the distance theslot 716 can close. The T-slots 718 can be reduced in length or removedin the more proximal regions of the flexible region of the outer tube710. Elastomeric bumpers or fillers can be added to some of the partiallateral slots 716 to reduce the amount the partial lateral slots 716 cancompress. Once the partial lateral slots 716, associated with theT-slots 718 have closed under bending of the outer tube 710, furtherbending is resisted and is substantially arrested. By tailoring thewidth and spacing of the partial lateral slots 716, a specific finalcurvature can be tailored for a given catheter.

FIG. 15A illustrates the outer tube 710 comprising the lumen 714, theproximal tube wall 712, the plurality of partial lateral slots 716, theplurality of T-slots 718, a short partial lateral slot 1502, a slightlylonger partial lateral slot 1504, and a standard length lateral slot 716but with a shortened T-slot 1506.

Referring to FIG. 15A, the most proximal partial lateral slot 1502penetrates less than the standard partial lateral slots 716. The second(moving distally) partial lateral slot 1504 is slightly longer than slot1502 and therefore is more flexible in that region and requires lessforce to generate bending. The third partial lateral slot comprises theshortened T-slot 1506 which reduces the ability of the tubing to bendgiven a constant bending force.

FIG. 15B illustrates the inner tube 720 comprising the lumen 724, theproximal region 722, the connected side 732, the distal end 730, thesharpened tip 1302, and a beveled lead-in 1510 at the proximal end ofthe distal end 730.

Since, during use of the steerable transseptal needle, the needle isadvanced distally through an already placed introducer, sheath, or guidecatheter, it is beneficial that the straight steerable transseptalneedle be capable of advancing through any curvatures in the alreadyplaced introducer, sheath, or guide catheter. Thus. In certainembodiments, the bevel is oriented such that the pointed point of thesharpened tip 1302 is oriented toward the direction of bending. In thisway, the steerable transseptal needle, when in its straightconfiguration, can be pushed against into the curved region of theintroducer, sheath, or guide catheter and not have the sharp point diginto the wall of the introducer, sheath, or guide catheter. The side ofthe sharpened tip 1302 away from the sharp point can further be roundedsomewhat to make it even more atraumatic and smooth so it can skate orsled along the curvature of the introducer, sheath, or guide catheterwithout digging out any material from the wall of the introducer,sheath, or guide catheter.

Referring to FIG. 15B, the proximal end of the disconnected region canbe moved distally to increase the stiffness of the inner tube 720 in aspecific region, generally the most proximal part of this distal,flexible region.

In certain preferred embodiments, it is beneficial that the inner tube720 can sustain compression to generate bending of the outer tube 710 atthe distal end back to straight after being curved and even to bendbeyond straight in the other (or opposite) direction. In order tosustain compression, it is beneficial that the disconnected side 734 beseparated from the connected side 732 at or near substantially thecenter or midpoint of the tubing. Depending on the width of the slot 726separating the disconnected side 734 from the connected side 732, thelocation of the slot can be offset from the midpoint but this isdependent on the wall thickness of the inner tube 720 and the angle ofthe slotting. In a preferred embodiment, interference exists between thedisconnected side 734 and the connected side 732 such that thedisconnected side and force transmitting member cannot movesubstantially inward, a situation that would have negative effects ofobstructing the lumen, restricting fluid flow therethrough, trappingstylets or other catheters that need to move longitudinally therein, orbuckling sufficiently to prevent application of longitudinal compressionforces on the connected side 732.

FIG. 16A illustrates a lateral cross-sectional view an inner tube 720nested inside an outer tube 710 and separated from the outer tube 720 bya radial gap 1602 in the flexible region of an articulating septal punchwherein the inner tube 720 is separated by a split or gap 726 into twoapproximately or substantially equal parts, a connected side 732 and adisconnected side 734, approximately (or substantially) at the midlineor centerline of the cross-section.

FIG. 16B illustrates a lateral cross-sectional view an inner tube 720nested inside an outer tube 710 and separated from the outer tube 720 bya radial gap 1602 in the flexible region of an articulating septal punchwherein the inner tube 720 is separated by a split or gap 726 into twosubstantially unequal parts, a connected side 732 and a disconnectedside 734, substantially offset from the midline or centerline of thecross-section.

Referring to FIGS. 16A and 16B, the disconnected side 734 is retained inclose proximity to the outer tube 710 by its stiffness and its inabilityto deform such that the edges of the disconnected side 734 can passbeyond the edges of the connected side 732 and thus the two sides 732and 734 are retained radially displaced from centerline. If the gap 726were too large or either side 732, 734 were small enough to fit withinthe edges of the other side, then displacement of one side toward thecenterline and confounding of the off-center orientation of theconnected side 732 or 734 would occur leading to buckling of theconnected side 732 in compression and inability to straighten out a benttransseptal needle. Another problem might be loss of torqueability andpredictability of the direction of bending. Both embodiments shown inFIGS. 16A and 16B maintain circumferential and radial orientation of theinner tube connected side 732 relative to the disconnected side 734 andpromote high precision deflection of the distal tip.

In preferred embodiments, the radial gap 1602 is minimized and isretained between about 0.0005 to 0.002 inches when the needle is about0.050 in outside diameter. Furthermore, the split or gap 726 should beas minimal as possible and in preferred embodiments can range from about0.002 inches to about 0.015 inches with a gap of about 0.004 to 0.010inches being most preferable.

The embodiments presented in FIGS. 7 through 16 describe a system thatdoes not use pull wires or push rods. There are no side lumens requiredin either the outer tube or the inner tube. Such side lumens, as foundin certain prior art catheters, require extensive cross-sectional areabe used to surround the side lumens and take away from the potentialarea for the central lumen since the outside extent of the catheter islimited. The use of control rods or pull wires requires such as those incertain prior art catheters, retaining these structures along one sideof the outer tube so it does not obstruct the lumen, which is needed forstylets, fluid injection, radiopaque dye injection, and the like. Sidelumens or channels are necessary to retain a pull wire or control rod inthe correct location so as to provide correct off center forces to bendthe distal end. The side lumens are also necessary to keep the controlrod or pull wires out of the central lumen which needs to remain openand substantially circular. The system disclosed herein, however,retains a high degree of column strength, maximum torqueability, thelargest possible central lumen, and a very strong control and steeringfunction or capability. Furthermore, the side lumens or channels arenecessary to maintain spatial (rotational orientation) for thearticulating distal end of the device. Without the side lumens orchannels permitting axial slidability but generating radial retention,the pull wires or pushrods would be free to migrate around within thecentral lumen of the device and could bend the device in an unwanteddirection. Long catheters or needles with relatively smallcross-sectional areas are highly subject to torque and rotationalmisalignment and some method must be employed to retain the correctcircumferential location of the articulating apparatus.

Furthermore, a pull-wire as used in prior art devices is incapable ofgenerating compression against the distal end of the device so apull-wire could not, under compression, move or articulate the distalend of the device. The pull-wire, under tension, can move or articulatethe distal end and would require some sort of counterforce such as anopposing pull-wire, shape memory metal, or spring return biasing to movethe distal end in the reverse direction. A pull-wire with a diameter ofabout 0.010 inches (0.0000785 square inches) would sustain tension loadsof about 500,000 PSI, to generate a pull force of 40 pounds or 250,000PSI to generate a pull force of 20 pounds, beyond the capability of mostknown metals or polymers. Forces exceeding 20 pounds can be necessary tocause bending and stiffening of a Brockenbrough needle to generate theappropriate column strength and bending resistance such that the fossaOvalis can be penetrated by the needle. An unconstrained push-rod orcontrol rod of almost any diameter will buckle under these types ofloads and be unable to generate oppositional forces under compression toarticulate the distal end in the reverse direction sufficiently to makethe device clinically acceptable.

However, a tubular or cylindrical central control device can maintainits structure in compression, maintain circumferential location withinthe outer cylindrical, axially elongate tube, maintain precise control,maintain sufficient tensile strength to exert forces up to and exceeding40 pounds, and maintain a central lumen larger than any other type ofsteerable device. The resistance to buckling occurs even when the innertube is slotted longitudinally because the inner tube is constrainedwithin the outer tube using very tight tolerances that will not let theinner tube bend out of its straight orientation, even under compression.

FIG. 17A illustrates a lateral cross-sectional view of the shaft 1700 ofa steerable needle or punch. The shaft comprises an outer tube 710further comprising a lumen 1710, a plurality of control rods 1702, aplurality of control rod spaces 1706, and a resultant central lumen1712.

Referring to FIG. 17A, the control rods 1702 are slidably disposedwithin the lumen 1710 outer tube 710, as well as relative to each other.The illustrated embodiment shows three control rods 1702, which can alsobe termed push rods, pull rods, or linkages, all of which include themechanical properties to be able to exert compression as well astension, and optionally torque, on an object being controlled. In someembodiments, one or more of the plurality of control rods 1702 can serveas a control rod retainer and not be affixed to any specific item. Thecontrol rods 1702 are affixed at their distal end to the outer tube,distal to a region of increased flexibility or bendability relative to amore proximal region of the outer tube 710. The plurality of controlrods 1702, are retained away from the resultant central lumen 1712 andsubstantially against the inner diameter of the outer tube 710 by thenarrow spacing 1706. The three control rods 1702 are configured toprovide for steering, deflection, or articulation of the distal end ofthe steerable needle or punch about multiple axes. Each control rod 1702can be moved independently, or in concert, along the longitudinal axisunder the influence of different actuators, controllers, hydraulicactuators, electrical actuators, pneumatic actuators, levers, knobs,jackscrews, or the like.

The outer tube 710, the control rods 1702, or both, can be fabricatedfrom materials such as, but not limited to, polyimide, polyamide,polyester, polyurethane, silicone, PEEK, PTFE, PFA, FEP, stainlesssteel, nitinol, titanium, cobalt nickel alloys, and the like.

FIG. 17B illustrates a lateral cross-sectional view of anotherembodiment of the shaft 1712 of a steerable needle or punch. The shaft1712 comprises an outer tube 710 further comprising a lumen 1710, aplurality of control rods 1704, a plurality of control rod spaces 1708,and a resultant central lumen 1714. The shaft 1712 further comprises anintermediate or inner tube 1716 which can serve as a keeper and as afluid-tight barrier, or liner, to prevent the migration of fluids, gasor liquid, across so as to maintain the central lumen leak-free andfluid impermeable central lumen 1718.

Referring to FIG. 17B, the inner tube 1716 can be fabricated frommaterials such as, but not limited to, polyimide, polyamide, polyester,polyurethane, silicone, PEEK, PTFE, PFA, FEP, stainless steel, nitinol,titanium, cobalt nickel alloys, and the like. The wall thickness of theinner tube can range from about 0.0005 inches to about 0.010 inches,with a preferred range of about 0.0007 to about 0.005 inches. The innertube 1716 can be affixed to the hub (not shown) at the proximal end andto the distal end of the outer tube 710, either directly or through anintermediary structure which could include a bonding ring or at leastone of the control rods 1702.

FIG. 18A illustrates a lateral cross-sectional view of anotherembodiment of the shaft 1800 of a steerable needle or punch. The shaft1800 comprises the outer tube 710 further comprising a lumen 1810, acontrol rod 1804, a control rod retainer 1806, guide, or keeper, aplurality of control rod spaces 1808, and a resultant central lumen1814. The shaft 1800 further comprises an intermediate or inner tube1716 which can serve as a keeper and as a fluid-tight barrier, or liner,to prevent the migration of fluids, gas or liquid, across so as tomaintain a central lumen leak-free and fluid impermeable central lumen1818. A stylet 1812 is slidably disposed within the fluid impermeablecentral lumen 1818.

Referring to FIG. 18A, the control rod 1804 is slidably disposed withinthe lumen 1810 and retained against or near the internal wall of theouter tube 710 by the control rod retainer 1806. The plurality ofcontrol rod spaces 1808 between the control rod 1804 and the control rodretainer 1806 are intentionally kept as small as possible withoutgenerating excessive friction that would hinder longitudinal relativemovement between the control rod 1804 and the control rod retainer 1806,as well as between the control rod 1804 and the outer tube 710. In theillustrated embodiment, the plurality of control rod spaces 1806 areabout 0.002 inches wide while the radial distance between the outer wallof the control rod and the inner wall of the inner tube is about 0.001inches. These spaces could be increased up to, but not beyond, the pointwhere the retaining function of the control rod retainer 1806 isdefeated and the control rod 1804 can move laterally into the center ofthe lumen 1814. The outer tube 710 is shown with a 0.050 inch OD and awall thickness of about 0.006 inches with a range of about 0.001 to0.020 inches. The control rod 1804 is illustrated with a wall thicknessof about 0.008 inches but can range from about 0.001 to about 0.020inches.

FIG. 18B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 1820 of a steerable needle or punch. The shaft1820 comprises the outer tube 710 further comprising the lumen 1810, twocontrol rods 1822, a control rod retainer 1806, guide, or keeper, aplurality of control rod spaces 1824, and a resultant central lumen1814. A stylet 1812 is slidably disposed within the central lumen 1814.

Referring to FIG. 18B, the control rod retainer 1806 can be affixed atthe distal end of the outer tube 710, it can be affixed at a hub (notshown), or it can be affixed to the outer tube at a point intermediatethe hub and a bendable region in the outer tube 710. In a preferredembodiment, the control rod retainer 1806 is affixed to the outer tubeat one axial location only. In another embodiment the control rodretainer 1806 is not affixed to the outer tube or the inner tube, butrather rides loosely within the outer tube 710 held in place by thecontrol rods 1822. This structure applies to all the control rods andcontrol rod retainers described within this specification.

The two control rods 1822 are affixed at their proximal end to a hub(not shown) or a control mechanism within a hub (not shown) allowing thecontrol rods 1822 to be independently moved longitudinally, or axially,relative to the outer tube 710, under manual or assisted control. Suchassisted control includes, but is not limited to, rotational electricmotors, pneumatic actuators, stepping motors, linear electric motors,hydraulic actuators, and the like and may further be controlled bycomputers, robotic devices, or other automated control systems. The twocontrol rods 1822 can, in other embodiments, be one or both affixeddirectly to the hub, or through an intermediary member, such that anyrelative motion between the control rods and the outer tube is broughtabout by moving the outer tube by an actuator while the control rods,one or both, remain affixed to the hub, directly or through anintermediary member such as another tube, anchor, fastener, or the like.Affixation can be performed using methods and devices such as, but notlimited to, welds, laser welds, silver solder, fasteners, adhesives,mechanical interlock, ultrasonic welds, or the like.

At the distal end, the control rods 1822 can be affixed directly to theouter tube 710 distal to a region of enhanced flexibility or through anintermediary such as a separate tube, linkage, control rod, fastener, orthe like. The control rods 1822 can be affixed at a same point or atdifferent locations along the circumference or longitudinal axis of theouter tube 710.

FIG. 18C illustrates a side view of a control rod and keeper system 1850comprising a c-cross-sectional shaped control rod 1804 and ac-cross-sectional shaped control rod keeper, guide, or retainer 1806.This configuration is shown in lateral cross-section in FIG. 18A. Thecontrol rod 1804 can extend or run substantially the entire workinglength of the steerable needle between a hub (not shown) and a regiondistal to any deflectable or steerable regions of the outer tube 710(refer to FIGS. 18A and 18B). The control rod 1804 can also beconfigured to retain its C-shape only within the approximate region of abendable or articulating region of the outer tube 710. In other areas,proximal and distal to the bendable region, the control rod 1804 can beaffixed or integral to a pusher rod, which can be solid or hollow, orother tubular structure. The control rod 1804 is affixed, or integral toa distal tubing extension 1854, which can be optionally terminated witha sharp point, as shown, or with a rounded blunt end, with a tapereddilator, or the like. The distal tubing extension 1854 steps up, in theillustrated example, to a larger diameter at the point 1860. The distaltubing extension 1854 can be integral, or affixed to the control rod1804 or the control rod guide 1806 by a weld, adhesive bond, mechanicalfastener, solder joint, brazing joint, or the like.

Referring to FIG. 18C, the c-shaped control rod guide or retainer 1806can be completely disconnected from the control rod 1804, or it can beaffixed at a point distal to the flexible region, at a point proximal tothe flexible region, but not both proximal and distal. In otherembodiments, the control rod retainer 1806 can be affixed to the outertube 710 but not to the control rod 1804. The control rod retainer 1806serves the function of forcing the control rod 1804 laterally off-centerto maintain off-center within the outer tube 710 and for filling thelumen of the outer tube 710 to prevent collapse of the lumen and kinkingduring articulation or bending.

FIG. 19A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 1900 of a steerable needle or punch. The shaft1900 comprises the outer tube 710 further comprising the lumen 1910, oneor more “V” shaped control rod 1902, a resultant central lumen 1910. Astylet 1812 can be slidably disposed within the central lumen 1910.

Referring to FIG. 19A, the V-shaped control rod 1902 can be slidablydisposed within the lumen 1910 of the outer tube 710 such that it can beaxially displaced without substantial resistance, yet it is stillconstrained against substantial lateral movement due to the spacerestrictions within the lumen 1910.

FIG. 19B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 1920 of a steerable needle or punch. The shaft1920 comprises the outer tube 710 further comprising the lumen 1910, oneor more “U” shaped control rod 1922, a resultant central lumen 1910. Thestylet 1812 can be slidably disposed within the central lumen 1910.

Referring to FIG. 19B, the U-shaped control rod 1922 can be slidablydisposed within the lumen 1910 of the outer tube 710 such that it can beaxially displaced without substantial resistance, yet it is stillconstrained against substantial lateral movement due to the spacerestrictions within the lumen 1910.

Referring to all the control rods disclosed herein, these control rodscan extend the entire length of the device from the hub or handle to aregion distal to any flexible regions or regions of enhanced bendabilityin the outer tube. The control rods can also be affixed or integral torods, tubing, or other structures extending part way through the devicebut not traversing the flexible regions or regions of enhancedbendability. The control rods can be affixed to the hub or handle by wayof an anchor, weld, adhesive, mechanical interlock, actuator, or thelike. The control rods can further comprise hinges or areas ofsubstantially increased flexibility proximate one or both of the ends,proximal and distal.

FIG. 20A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2000 of a steerable needle or punch. The shaft2000 comprises the outer tube 710 further comprising the lumen 1910, oneor more hollow, round control rods 2002, the control rods furthercomprising a resultant central lumen 2004. This arrangement does notleave room for a large diameter, round stylet but it does provide for asubstantial lumen for fluid flow 1910 within the outer tube 710.

FIG. 20B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2020 of a steerable needle or punch. The shaft2020 comprises the outer tube 710 further comprising the lumen 1910, oneor more hollow, round control rods 2002, and an off-center but full sizestylet 1812. This arrangement does provide for a lumen for fluid flow1910 within the outer tube 710 and the stylet 1812 further provides thefunction of the control rod retainer, when the stylet 1812 is in placewithin the lumen 1910.

FIG. 21A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2100 of a steerable needle or punch. The shaft2100 comprises the outer tube 710 further comprising the lumen 1910, arectangular control rod 2102, the control rod 2102 further comprising acentral lumen 2104. A round stylet can be retained within the lumen 2104and it does provide for a substantial lumen 1910 for fluid flow withinthe outer tube 710.

Referring to FIG. 21A, the distal end of the control rod 2102 can beaffixed to the outer tube 710 on one side or another thus generatingsome offset forces to bend the outer tube 710.

FIG. 21B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2120 of a steerable needle or punch. The shaft2200 comprises the outer tube 710 further comprising the lumen 1910, andan I-Beam shaped control rod 2122. A round stylet cannot be retainedwithin the lumen 1910 but it does provide for a substantial lumen 1910for fluid flow within the outer tube 710, even greater than that for theembodiment shown in FIG. 21A. Note that the edges of the control rods2122 and 2102 in FIGS. 21A and 21B are rounded to provide a smoother fitwithin the lumen 1910, but this rounding, or even part of it, isoptional.

FIG. 22A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2200 of a steerable needle or punch. The shaft2200 comprises the outer tube 710 further comprising the lumen 1910, anda round, solid control rod 2202. A round stylet (shown in FIG. 22B) canbe retained within the lumen 1910 by moving the control rod 2202off-center and it does provide for a substantial lumen 1910 for fluidflow within the outer tube 710 but little control over the radial orcircumferential position of the control rod within the outer tube 710 isprovided.

FIG. 22B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2220 of a steerable needle or punch. The shaft2220 comprises the outer tube 710 further comprising the lumen 1910, anda round, hollow control rod 2222 further comprising a lumen 2204. Thestylet 1812 is retained within the lumen 2204 of the hollow control rod2222.

FIG. 23A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2300 of a steerable needle or punch. The shaft2300 comprises the outer tube 710 further comprising the lumen 1910, anda round, hollow control rod retainer 2302 further comprising a centrallumen 2304 and a plurality of retainer grooves 2306, and a plurality ofcontrol rods or pull wires 2308. A round stylet (shown in FIG. 22B) canbe retained within the lumen 2304 but is left out of this illustration.

Referring to FIG. 23A, the control rods or pull wires 2308 areillustrated as solid but can comprise structures such as, but notlimited to, stranded, tubular, circularly braided, flat braided,continuous tubular, slotted tubular, or the like. The grooves 2306,which can be termed channels, slots, or the like, are beneficially cutor formed into the exterior of the control rod retainer 2302. In otherembodiments, these grooves 2306 could be replaced by one or moreoff-center lumens (not shown) within the cross-section of the controlrod retainer 2302. The control rod retainer 2302 can be affixed at oneor more points within the outer tube 710 or it can be free floating. Thecentral lumen 2304 is capable of accepting another wire or control rod,a stylet, or fluid.

FIG. 23B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2320 of a steerable needle or punch. The shaft2320 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved, c-shaped control rod retainer 2322 and an arcuate orc-shaped cross-section control rod 2328. The control rod 2328 and thecontrol rod retainer 2322 are separated by a plurality of gaps or spaces2324. A round stylet (not shown here but shown in FIG. 22B) can beretained within the remaining lumen 2326.

Referring to FIG. 23B, the spaces 2324 between the control rod retainer2322 and the control rod 2328 do not radiate from the center in a radialdirection but rather at an angle from the radial direction. The spaces2324 between the control rod retainer 2322 and the control rod 2328 aredrawn at about 0.002 inches spacing but that spacing could be betweenabout 0.0005 and 0.015 inches with a preferable spacing of between about0.001 and 0.008 inches.

FIG. 24A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2400 of a steerable needle or punch. The shaft2400 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved control rod 2402 which subtends approximately 270degrees of circumference on the inside diameter of the outer tube 710. Around stylet 1812 is illustrated as slidably, and removably, retainedwithin the remaining lumen 1910 which is defined by the curvature in thecenter of the arcuate control rod 2402.

Referring to FIG. 24A, the arcuate control rod 2402 is retained againstthe side wall of the outer tube 710 by its shape, being greater than 180degrees in circumference. Because the arcuate control rod 2402 is not afull 360 degree control rod, it will have somewhat increased bending anddecreased resistance, relative to a fully circular control rod, tolateral forces imposed thereupon.

FIG. 24B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2420 of a steerable needle or punch. The shaft2420 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved control rod 2428 which subtends approximately 180degrees of circumference on the inside diameter of the outer tube 710,along with an arcuate control rod retainer 2422 which further subtendsapproximately 180 degrees within the outer tube 710. A plurality ofslits, or slots, 2426 separate the control rod 2428 and the control rodretainer 2422.

The control rod retainer 2422 of FIG. 24B is smaller in wall thicknessthan that of the control rod 2428 to permit greater fluid flow ratestherein and still keep the control rod 2428 against the inside wall ofthe outer tube 710 and offset from the centerline.

FIG. 25A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2500 of a steerable needle or punch. The shaft2500 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved control rod 2502 which subtends approximately 180degrees of circumference on the inside diameter of the outer tube 710,along with an arcuate control rod retainer 2504 which further subtendsapproximately 180 degrees within the outer tube 710. A plurality ofslits, or slots, 2506 separate the control rod 2502 and the control rodretainer 2504. This configuration is similar to that shown in FIG. 18Aexcept that the control rod 2502 and the control rod retainer 2504subtend a greater arc than the device of FIG. 18A and thus, the gaps2506 are much smaller, in this case about 0.002 inches and leaving verylittle room for lateral displacement of the control rod 2502. The outertube 710, as shown, is an 18 gauge tube with an outside diameter ofabout 0.050 inches and an inside diameter of about 0.038 inches. Thisdiameter can change to suit the occasion but the concept of tighttolerances between the inner and outer structures is important inretaining alignment and off-center positioning.

FIG. 25B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2520 of a steerable needle or punch. The shaft2520 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved control rod 2522 which subtends approximately 180degrees of circumference on the inside diameter of the outer tube 710,along with an arcuate control rod retainer 2524 which further subtendsapproximately 180 degrees within the outer tube 710. A plurality ofslits, or slots, 2526 separate the control rod 2522 and the control rodretainer 2524. This configuration is similar to that shown in FIG. 25Aexcept that the control rod 2522 and the control rod retainer 2524subtend a significantly reduced arc than the device of FIG. 25A andthus, the gaps 2526 are much larger, in this case about 0.009 inches andleaving much more room for lateral displacement of the control rod 2522.As in FIG. 25A, the outside arc of the control rod 2522 and the controlrod retainer 2524 is a close fit with the inside diameter of the outertube 710, having only a gap of about 0.001 inches. Since the materialsused in all the elements can be metallic, friction from longitudinalrelative translation is low and is not a major factor relative to theforces needed to bend the structure.

FIG. 25C illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2540 of a steerable needle or punch. The shaft2540 comprises the outer tube 710 further comprising the lumen 1910, anarcuate or curved control rod 2542 which subtends approximately 180degrees of circumference on the inside diameter of the outer tube 710,along with an arcuate control rod retainer 2544 which further subtendsapproximately 180 degrees within the outer tube 710. A plurality ofslits, or slots, 2546 separate the control rod 2542 and the control rodretainer 2544. This configuration is similar to that shown in FIG. 25B,with approximately the same slot width 2546, except that the control rod2542 and the control rod retainer 2544 comprise a significantly reducedoutside diameter than the device of FIG. 25B, and thus, the gap 2548between the control rod 2542 and the inside diameter of the outer tube710, as well as that of the control rod retainer and the inside diameterof the outer tube 710 are much larger and leave much more room forlateral displacement of the control rod 2542 and the retainer 2544.

FIG. 26A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2600 of a steerable needle or punch. The shaft2600 comprises the outer tube 710 further comprising the lumen 1910. Theshaft 2600 further comprises a plurality of solid control rods or wires2602, an intermediate or inner tube 2606, and a stylet 1812. Theplurality of control rods or wires 2602 ride within the annulus 2610comprised between the outside of the intermediate or inner tube 2606 andthe inside of the outer tube 710.

FIG. 26B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2620 of a steerable needle or punch. The shaft2620 comprises the outer tube 710 further comprising the lumen 1910. Theshaft 2620 further comprises a plurality of hollow control rods or wires2622, an intermediate or inner tube 2606, and a stylet 1812. Theplurality of control rods or wires 2622 ride within the annulus 2610comprised between the outside of the intermediate or inner tube 2606 andthe inside of the outer tube 710. The hollow control rods or wires 2622can be tubular in configuration and either solid wall or fenestrated,woven, braided, or the like.

Referring to FIGS. 26A and 26B, the inner tube 1606 restrains thecontrol wires or rods 1606, 2622 radially off-center but does notprovide much resistance against circumferential misalignment.

FIG. 27A illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2700 of a steerable needle or punch. The shaft2700 comprises the outer tube 710 further comprising the lumen 1910 anda solid, full diameter control rod 2702 that is slidably disposed orconstrained within the lumen 1910 with adequate wall clearance such thatminimal friction is encountered but maximum bracing against kinking ofthe outer tube 710 is provided.

FIG. 27B illustrates a lateral cross-sectional view of anotherembodiment of a shaft 2720 of a steerable needle or punch. The shaft2720 comprises the outer tube 710 further comprising the lumen 1910 anda plurality of solid, partial diameter control rods 2722 that areslidably disposed within the lumen 1910 with adequate wall clearance,and comprise gaps or space 2726 from each other, such that minimalfriction is encountered but maximum bracing against kinking of the outertube 710 is provided. The plurality of control rods 2722 can be hollowor solid. They can be fabricated from tubes, and filling the center, orfrom a round, solid bar. The central gap 2726 can be fabricated byslotting a tube or bar or by forming the two parts separately.

FIG. 28A illustrates a lateral (side) view of a distal, deflectableregion 2800 of a steerable needle or punch. The distal deflectableregion 2800 comprises the outer tube 2802, with a first plurality ofradially directed, partial cuts or gaps 2804 oriented in a firstdirection, and a second plurality of radially directed partial cuts orgaps 2806 oriented in a second direction. The gaps 2802 and 2804 areformed in the wall such that not all cu 2802 cuts are grouped togetherbut are, in at least one case, interleaved with the cuts 2804. Thedistal deflect able region 2800 further comprises a first control rod1802, a second control rod 1804, and a control rod retainer or keeper1806, each separated by a plurality of slots 1810. The deflectableregion 2800 further comprises the first weld 2814 and the second weld2812.

Referring to FIG. 28A, the two control rods 1802 and 1804 are able toseparately apply off-center forces on the outer tube 2802 and, due tothe selective ability of the outer tube to bend in the first and seconddirections, cause the outer tube to flex or articulate in these twodirections. The stability of the control rod 1802 allows the secondcontrol rod 1804 to flex the tube without closing or opening the gaps2804 but instead closing or opening the gaps 2806. The same condition istrue for the control rod 1804 stabilizing longitudinal movement of theouter tube against opening or closing of the gaps 2806 in a specificdirection so that the control rod 1802 can flex the outer tube in thedirection of the gaps 2804.

The control rods 1802 and 1804 can be separately affixed to the outertube 2802 distal to the articulating region or they can be affixedtogether and to the outer tube 2802 distal to the articulating region.The control rods can be affixed together, to the outer tube, or to anintermediary structure such as another tube using methods such as, butnot limited to, welding, soldering, fasteners, mechanical interlock,adhesive bonding, and the like. In the illustrated embodiment, the firstcontrol rod 1802 is affixed to the outer tube by the first weld 2814 andthe second control rod 1804 is affixed to the outer tube by the secondweld 2812. These welds 2812, 2814 can preferably be laser welds orsilver soldered joints although the other listed methods can also beused.

FIG. 28B illustrates a cross-section 2820 of the tubing 2800 in thedistal articulating region as viewed in the direction shown. Thecross-section 2820 comprises the outer tube 2802, the central lumen1808, the first control rod 1802, the second control rod 1804, thecontrol rod retainer 1806, and the plurality of gaps 1810.

FIG. 29A illustrates a lateral (side) view of a distal, bi-directionallydeflectable region 2900 of a steerable needle or punch. The distalbi-directionally deflectable region 2900 comprises a first outer tuberegion 2906, with a first plurality of radially directed, partial cutsor gaps 2916 oriented in a first direction, a second outer tube region2904 comprising and a second plurality of radially directed partial cutsor gaps 2914 oriented in a second direction. The cuts or fenestrations2914 and 2816 are formed in the wall such that all cuts or gaps 2914 or2916 are grouped together in their respective outer tube regions 2904and 2906. The distal deflect able region 2900 further comprises a firstcontrol rod 1802, a second control rod 1804, and a control rod retaineror keeper 1806, each separated by a plurality of slots 1810. Thedeflectable region 2900 further comprises the first weld 2908 and thesecond weld 2910, which are located at different axial locations alongthe tubing. The distal end of the outer tube 2918, located axiallydistal to the deflectable region, is terminated distally by a sharppoint 2920 and affixed to one or more of the control rods 1802, 1804,the control retainer 1806, the distal-most outer tube 2926, or one ormore of these by a fixation point, arc, or ring 2922, which can be aweld, adhesive bond, solder joint, mechanical fastener, integralfabrication, intermediary structure or the like.

Referring to FIG. 29A, the two control rods 1802 and 1804, affixed tothe outer tube at different locations immediately distal to theirrespective articulating regions 2904, 2906 by welds 2910 and 2908, areable to separately apply off-center forces on the outer tube regions2904 and 2906 and cause the outer tube to flex or articulate in thesetwo directions within their specific locations 2906, 2904. The stabilityof the control rod 1802, in both compression and tension, allows thesecond control rod 1804 to flex the 2906 tube without closing or openingthe gaps 2914 but instead closing or opening the gaps 2916. The samecondition is true for the control rod 1804 stabilizing longitudinalmovement of the outer tube against opening or closing of the gaps 2916in a specific direction so that the control rod 1802 can flex the outertube in the direction of the gaps 2914.

The control rods 1802 and 1804 are separately affixed to the outer tubedistal to their respective articulating. The control rods can be affixedto the outer tube, or to an intermediary structure such as another tubeusing methods such as, but not limited to, welding, soldering,fasteners, mechanical interlock, adhesive bonding, and the like. In theillustrated embodiment, the first control rod 1802 is affixed to theouter tube by the first weld 2910 and the second control rod 1804 isaffixed to the outer tube by the second weld 2908. These welds 2908,2910 can preferably be laser welds or silver soldered joints althoughthe other listed methods can also be used.

FIG. 28B illustrates a cross-section 2950 of the tubing region 2904 inthe distal articulating region as viewed in the direction shown. Thecross-section 2950 comprises the outer tube 2904, the central lumen1808, the first control rod 1802, the second control rod 1804, thecontrol rod retainer 1806, and the plurality of gaps 1810.

FIG. 30A illustrates a lateral (side) view of a distal, bi-directionallydeflectable region 3000 of a steerable needle or punch. The distalbi-directionally deflectable region 3000 comprises an outer tube 3006,with a plurality of radially directed, partial cuts or gaps 3008oriented in a first direction, and further comprising a distal end 3010.The distal region 3000 further comprises a hollow tubular control rod3002, a central lumen 3004, a distal weld 3016, a tubing extension 3012optionally terminated by a sharp point 3014, and a hinge region 3020created, in this embodiment, by a cut 3018 in the control rod 3002.

Referring to FIG. 30A, the cuts or fenestrations 3008 are formed in thewall such that all cuts or gaps extend and transect approximately 50% ofthe diameter of the tube. This transection or cut can range from about10% to about 90% of the diameter with a preferred range of about 30% toabout 70% of the diameter. The transaction can be a simple cut with arounded end, as illustrated, it can have substantially no rounding, orit can comprise T-slots at the end to facilitate bending depending onthe strength of the material and resistance to bending. The transectioncan comprise a width of about 0.001 to about 0.020 inches with apreferred range of about 0.005 to about 0.015 inches and a mostpreferred range of about 0.007 to about 0.012 inches. The control rod3002 can be affixed to the distal-most outer tube 3010, distal to anyflexibility enhancing features such as the transections 3008, by afixation point, arc, or ring 3016, which can be a weld, adhesive bond,solder joint, mechanical fastener, integral fabrication, intermediarystructure or the like.

This configuration retains the internal lumen as mostly fluid-tight andleak free, except in the region of the hinge cutout 3018 in the controlrod 3002. To prevent leakage through the slots 3008 from the slot 3018,a pressure shroud 3018 is affixed around the exterior of the outer tube.This pressure shroud can comprise, for example, a shrink wrapped orbonded tube of polyester, polyurethane, PTFE, FEP, PFA, or the like. Thewall thickness of the pressure shroud 3018 can range from about 0.00025inches to about 0.010 inches with a preferred range of about 0.0005 toabout 0.005 inches and a most preferred range of about 0.0007 to about0.002 inches.

The central lumen 3004 is capable of serving as a leak-free channel forinfusion and withdrawal of fluids, both liquid and gas, and can serve asa pressure monitoring lumen, for example, without concern for migrationof materials out of, or into, the sides of the device.

The hinge 3020, generated by cutting a notch 3018 in the control rod3002 is optional. The hinge 3020 could also be fabricated using morestandard hinge construction comprising a pin and loops or by theinclusion of materials of elastomeric nature to permit flexing.

FIG. 30B illustrates a cross-section 3050 of the tubing region 3006 inthe distal articulating region as viewed in the direction shown. Thecross-section 3050 comprises the outer tube 3006, the central lumen3004, the hollow control rod 3002, and the gap 3522 between the controlrod 3002 and the outer tube 3006.

Referring to FIG. 30B, the gap 3522 needs to be enough to preventbinding of the control rod 3002 against the outer tube 3006 duringbending. The gap 3006 can be sized radially between about 0.001 and0.025 inches with a preferred gap of about 0.005 to about 0.020 inches,with a most preferred gap of about 0.010 to 0.015 inches.

FIG. 31A illustrates a side view, in partial breakaway, of the distalend of a steerable transseptal needle 3100 comprising an outer tube3112, an inner tube 3106, further comprising a lumen 3108 and a blunteddistal end 3110, a stylet 3102 further comprising a sharp, pointed,distal end 3104, which is shown retracted inside the lumen 3108, acontrol rod 3114, and a keeper or stay 3116.

Referring to FIG. 31A, the sharp tip 3104 can be formed integrally tothe stylet 3102. The sharp tip 3104 can be conical and be sharpened toangles ranging from about 10 degrees to about 60 degrees from thelongitudinal axis, per side. The blunted distal end 3110 of the innertube 3106 can comprise a full round approximately equal to the wallthickness, a taper, a chamfer, or the like. The inner tube 3106 is smallin diameter and is difficult to make completely non-sharp but it isblunted to the extent possible. The control rod 3114 is illustrated andextends within the bendable region of the steerable transseptal needle.Sufficient space can exist around the stylet shaft 3102 and within thelumen 3108 to permit fluids to be injected and withdrawn or pressuremeasurements to be taken. In another embodiment, the stylet wire shaft3102 can comprise one or more longitudinal slots (not shown) to increasefluid flow area therethrough. The stylet wire or shaft 3102 can alsohave a star shaped cross-section, a C-shaped cross-section, or the like.The sharp tip 3104 is retracted sufficiently inside the blunted end 3110that there is no risk of unwanted tissue or guide catheter shaftpuncture or damage while the steerable transseptal needle is beingadvanced or positioned. The piercing stylet in this embodiment iscapable of punching through tissue more sharply than the native distalend of the apparatus.

FIG. 31B illustrates a side view of the distal end of the steerabletransseptal needle 3100 with the stylet 3102 advanced beyond the blunteddistal end of the inner tube 3110 to expose the sharp tip 3104. Thesteerable transseptal needle comprises the outer tube 3112, the innertube 3106 with the blunted distal end 3110, the stylet 3102, shownadvanced, further comprising the sharp, pointed, distal end 3104, thecontrol rod 3114, and the keeper or stay 3116.

Referring to FIG. 31B, the sharp tip 3104 is advanced sufficiently toprovide for a clean tissue puncture and so that the pierced tissue canride over the stylet shaft 3102, over the blunted distal end 3110, andonto the outside of the inner tube 3106. Projection of the inner tube3106 beyond the outer tube 3112 is traditionally about 1.5 cm. Thisdistal projection distance of the inner tube 3106 can be maintained sothat the sharp tip 3104 projects beyond the 1.5 cm or the inner tube3106 projection can be reduced so that the sharp tip 3104 is positionedat approximately 1.5 cm (or less) from the outer tube 3112, when thestylet is fully advanced.

FIG. 32A illustrates a side view, in partial breakaway, of the distalend of a steerable transseptal needle 3200 comprising the outer tube3112, the inner tube, 3106 further comprising the lumen 3108 and theblunted distal end 3110, the stylet 3102 further comprising a neck down3210 to a smaller diameter more proximal stylet shaft 3208, the sharp,pointed, distal end 3104, which is shown retracted inside the lumen3108, the control rod 3114, the keeper or stay 3116, a radiopaque marker3202 further comprising a radiopaque marker lumen 3204, and a radiopaquemarker retainer 3206.

Referring to FIG. 32A, the radiopaque marker 3202 can comprise materialssuch as, but not limited to, tantalum, platinum, gold, platinum iridium,or the like. The radiopaque marker 3202 is preferably affixed within thelumen 3108 but can, in other embodiments, be affixed to the exterior ofthe inner tube 3106. The radiopaque marker 3202 can be affixed to thewall of the inner tube 3106, as is, or the inner tube 3106 wall can bemachined to create an increased diameter on the ID or a decreaseddiameter on the OD to accept the radiopaque marker 3202. The radiopaquemarker 3202 can be affixed to the inner tube 3106 by welding, adhesivebonding, swaging, a combination thereof, or the like. In an embodiment,the inner tube 3106 can be formed down to a smaller diameter after theradiopaque marker is installed to prevent the radiopaque marker fromever being dislodged.

FIG. 32B illustrates a side, partial breakaway view of the distal end ofthe steerable transseptal needle 3200 with the stylet 3102 advanced toexpose the sharp end 3104 distal to the distal end 3210 of the innertube 3202. The steerable transseptal needle 3200 comprises the outertube 3112, the inner tube 3106, further comprising the lumen 3108 andthe blunted distal end 3110, the stylet 3102, further comprising thesmaller diameter more proximal stylet shaft 3208, the sharp, pointed,distal end 3104, which is shown advanced and exposed beyond the end ofthe inner tube 3106, the inner tube lumen 3108, the control rod 3114,the keeper or stay 3116, the radiopaque marker 3202 further comprisingthe radiopaque marker lumen 3204, and the radiopaque marker retainer3206.

Referring to FIG. 32B, the lumen 3204 of the RO marker 3202 issufficiently large that the stylet wire 3102 can slidably projecttherethrough with no appreciable drag or binding. The RO marker lumen3204 should be at least approximately 0.002 inches larger in diameterthan the OD of the stylet shaft 3102.

FIG. 33A illustrates a side view, in partial breakaway, of the distalend of a steerable transseptal needle 3300 comprising all the elementsof the steerable transseptal needle 3200 of FIGS. 32A and 32B, butwherein the sharp pointed end 3104 of the stylet 3102 is replaced by abeveled, sharp end 3302. The beveled end 3302 can be angled at about 10degrees to about 60 degrees from the longitudinal axis of the styletwire 3102. The beveled end 3302 can further comprise one or more facets,not shown.

FIG. 34A illustrates a side view of a stylet hub 3400 comprising theproximal length of stylet wire 3102, the hub body 3402, furthercomprising a hub lumen 3416, a male Luer taper 3414, and a male Luerlock feature 3412, a spring housing 3404, a push cap 3406, a wireretaining tube 3408, a spring 3410, an O-Ring 3418, and an O-ringretainer 3420. The stylet hub 3400 is shown with the push cap 3406 andits spring container retracted, as biased by the spring 3410.

Referring to FIG. 34A, the hub body 3402, the spring housing 3404, thecap 3406, and the O-ring retainer 3420 can comprise plastic such as, butnot limited to, polycarbonate, polysulfone, PEEK, PVC, ABS, or the like.The parts can be assembled using adhesive bonding, solvent bonding,ultrasonic welding, interference snap fits, or the like. The springhousing 3404 slides axially over the OD of the hub body 3402 and thesetwo parts are not bonded together. The cap 3406 is affixed to the wireholding tube 3408 using adhesive bonding, a mechanical interference, orthe like. The stylet wire 3102 can be affixed to the holding tube 3408using laser welds, silver solder, crimping, mechanical fasteners, or thelike. The O-ring 3418 prevents fluid leakage through the lumen 3416 intothe interior of the spring housing 3404 where it could escape and causepatient hemorrhage. Air ingress through the lumen 3416 could also leadto an air embolism and thus needs to be prevented by this O-ring. Thespring 3410 can be fabricated from materials such as, but not limitedto, stainless steel, nitinol, titanium, cobalt nickel alloy, or thelike. In the illustrated embodiment, the spring 3410 is an open coil,when relaxed, but could also be a leaf spring or other spring structure.The spring 3410 biases the hub 3400 to keep the stylet 3102 fullyretracted except when activation is required. In the illustratedembodiment, the spring 3410 is fabricated from stainless steel andcomprises an OD of 0.25 inches and a wire diameter of about 0.01 to 0.03inches, with a preferred wire diameter of about 0.015 to 0.014 inches.

FIG. 34B illustrates a side view of the stylet hub 3400 with the springcompressed and the push cap 3406 and its spring housing 3404 fullyadvanced to compress the spring 3410. The stylet hub 3400 comprises theproximal length of stylet wire 3102, the hub body 3402, furthercomprising the hub lumen 3416, the male Luer taper 3414, and a male Luerlock feature 3412, the spring housing 3404, the push cap 3406, the wireretaining tube 3408, and the spring 3410. The stylet wire 3102 is nowadvanced distally due to distal relative motion of the push cap 3406.

FIG. 35A illustrates a side view of a stylet hub 3500 comprising the hubbody 3402 further comprising the Luer lock feature 3412, the male Luertaper 3414, an enlarged diameter grip 3504 around the male Luer lockfeature 3412, the spring housing 3404, the push cap 3406, and a safetyclip 3502.

Referring to FIG. 35A, the safety clip 3502 resides within thedepression created by the spring housing 3404 and the enlargement 3504.The safety clip 3502 comprises a grip region and a c-shaped section thatremovably snaps around the barrel of the hub body 3402. Thus, theC-shape comprise sufficient opening to permit easy attachment andrelease of the C-clip 3502 by grasping the grip region or handle. Thesafety clip 3502 prevents the user from advancing the spring housing3404 and cap 3406 distally. Once the safety clip is removed, the springhousing 3404 and cap 3406 can move distally, under spring compression,to force the stylet shaft 3102 distally. The safety can comprise otherstructures that permit such a safety feature. Such safety features cancomprise integral switches, control knobs, mechanical interlocks, or thelike.

FIG. 35B illustrates an oblique view of the stylet hub 3500, comprisingthe spring housing 3404, the Male Luer lock feature 3412, the male Luertaper 3414, and the removable safety clip 3502. The threads forming themale Luer lock feature 3412 can be clearly seen. These threads interlockwith threads on the flange of a female Luer lock connector to form abayonet mount or screw mount to securely maintain attachment. When fullysecured, the hub 3500 or 3400 are positioned precisely with relation tothe hub 3500 or 3400 on the steerable transseptal needle (FIG. 36), thusproviding for precise locating and function of the stylet tip protrusiondistance.

FIG. 36A illustrates an exterior side view of a steerable transseptalneedle 3600 with its distal end curved 90 degrees. The steerabletransseptal needle comprises the stylet 3102 (not shown because it isretracted), the stylet hub 3500, further comprising the stylet hubbutton 3404 and cap 3406, the safety clip 3502, the bendable region ofthe needle 900, the steerable transseptal needle hub 800, and theblunted distal end 3110.

Note that the stylet hub 3500 can be released and removed from the hub800 of the steerable transseptal needle 3600. Although a Luer lock isshown as the preferred attachment, any type of quick connect can be usedsuch as, but not limited to, mechanical fastener, bayonet mount, screwmount, or the like.

FIG. 36B illustrates the steerable transseptal needle of FIG. 36A withthe safety clip 3502 removed but the activation button 3404, 3406 on thestylet hub 3500 has not been advanced or depressed.

FIG. 36C illustrates the steerable transseptal needle of FIG. 36B withthe activation button 3404, 3406 on the stylet hub 3500 having beendepressed and causing the stylet 3102, and its sharp tip 3104, to beexposed distally beyond the end 3110 of the inner tube.

In other embodiments, the stylet hub can comprise a quick releasefeature for the spring. In these embodiments, when a control button ispushed, an intermediate structure is engaged and forces the stylet shaft3102 distally until a certain point is reached, wherein the intermediatestructure is disengaged and the spring forces the stylet shaft 3102proximally. This disengagement can result from mechanical action thatspreads holding features apart sufficiently to release the stylet shaft3102 and spring 3410. The disengagement can also occur by means of arotary intermediate device that turns such that the stylet shaft 3102and spring 3410 lose engagement and are allowed to be biased proximally.In this embodiment, the stylet sharp tip 3104 is never advanced for verylong and inadvertent advancement of the structure has less risk ofcausing damage to critical tissues because the sharp stylet tip 3104retracts faster than a human can push the device forward.

In yet other embodiments, the hub of the steerable transseptal needlecan comprise a side port that is operably connected to the central lumenof the steerable transseptal needle. This side port can be terminatedwith a female Luer lock and optionally a hemostasis valve or stopcock.This side port can be used to inject or withdraw fluids or to measurepressure while the piercing stylet system is in place and locked ontothe proximal end of the steerable transseptal needle.

FIG. 37 illustrates a top view of a steerable transseptal needle hubbody 3708 affixed to a three-way stopcock 3700. The stopcock 3700comprises a side port 3702 further comprising a lumen (not shown), whichis operably connected to the other lumens of the stopcock through thepetcock 3712, which allows both the side port 3702 and the proximalthrough port 3710 to be operably connected to a central lumen (notshown) of the hub 3708. The ends of the stopcock lumens are preferablyfemale Luer lock ports, but could also be regular threaded mounts, quickconnects, bayonet mounts, or the like. The piercing stylet hub 3500 isaffixed to the Luer threads of the proximal through port 3710.

FIG. 38 illustrates a side view of a faceted sharp distal end 3800 of apiercing stylet 3102. Also illustrated in FIG. 38 are the outer tube3106 and the blunted, generally laterally cut and rounded distal end3110 of the outer tube. The number of facets can range from 1 to 10 ormore with a preferred number of 2 to 4. Where the stylet tip is notfaceted, it can comprise a simple cone or bevel as Illustratedelsewhere. The facets can be cut at an angle of between about 5 andabout 45 degrees relative to the longitudinal axis of the sty let 3102.

FIG. 39A illustrates a side, partial breakaway view of a steerabletransseptal needle comprising a piercing stylet 3900 further comprisinga distal shaft 3902, the sharp distal tip 3104, a transition zone 3904,a cutout or cutaway section 3908, and a central shaft 3902. Thesteerable transseptal needle comprises the inner tube 3106, the outertube 3112, and the blunted distal end 3110 of the inner tube 3106, andone or more, optional, fenestration, window, opening, or hole 3910. Thecutaway region 3908 can run the entire length of the stylet wire or itcan terminate at a transition, as shown, to a substantially, completelyrounded distal end 3902. The cutaway region 3908 can project out thedistal end of the inner tube 3106 or it can fully reside within theinner tube 3106 when retracted, extended, or both. The window 3910 canpermit pressure measurement and fluid injection or removal therethroughwhen operably in communication with the cutaway region 3908.

FIG. 39B illustrates a lateral cross-section of a stylet wire 3900configured to facilitate fluid flow or pressure measurement while thestylet wire 3900 is in place within the lumen of a steerable transseptalneedle. The stylet wire 3900 has had its cross section reduced thuscreating a half-moon shaped shaft and creating a half-moon shaped lumen3908 within the inner tube 3106. The cross-section can be half-moonshaped, as illustrated, or it can be C-shaped, S-shaped, D-Shaped, Ushaped, or the like.

FIG. 40 illustrates a hub of a steerable transseptal needle safetypiercing stylet wherein the hub of the stylet comprises a quick releaseto actuate, and then retract the stylet. The stylet hub 4000 comprises apush button 4002, a first transmission arm 4004 further comprising afirst magnet 4006, a second transmission arm 4008 further comprising asecond magnet 4010 and a catch 4030, a stylet hub body 4012 furthercomprising a stop 4018, a stylet wire 4016 and a return spring 4014. Thehub 4020 of the steerable transseptal needle further comprises anelectrical connector 4022, operably connected to the inner tubing 4024or its anchor 4026. The outer tube of the needle is covered with aninsulating jacket 4028. The apparatus may also include a pressure jacketdisposed exterior to the outer tube wherein the pressure jacket preventsingress or egress of fluid through the fenestrated wall of theapparatus.

The stylet wire 4016 is affixed to the first transmission arm 4004.First magnet 4006 is affixed to the first transmission arm 4004 and thesecond magnet 4010 is affixed to the second transmission arm 4008. Thereturn spring 4014 is operably connected to the first transmission arm4004 to bias the first transmission arm 4004 proximally away from thesecond transmission arm 4008. The first 4004 and second 4008transmission arms as well as the spring 4014 reside with, and areradially constrained within a cavity within the stylet hub body 4012.The spring 4014, as well as the first and second transmission arms 4004and 4008 can move longitudinally within the cavity of the stylet hubbody 4012. The spring 4014 is affixed at one end to the stylet hub body4012 and to the second transmission arm 4008 such that the spring 4014,at rest, is uncompressed and distal movement of the second transmissionarm 4008 forces the spring 4014 into compression from which it wants torecover. The spring 4014 can also be used in tension using analternative layout. The stop 4018 within the stylet hub body 4012prevents unwanted distal motion of the second transmission arm 4008because of the stop 4030 interferes with the catch 4030. Thisinterference forces the first and second transmission arms and theirmagnets 4006 and 4010 apart after a predetermined travel.

The magnets 4010 and 4006 can comprise materials such as, but notlimited to, samarium cobalt, neodymium iron boron, iron, or the like.The magnets can comprise magnifier structures to optimize the magneticfields. The magnets can be configured, in a preferred embodiment, sothat opposite poles come together to provide attraction between themagnets, or wherein like poles come together to provide for repulsiveforces.

The electrical connector 4022 is integral or affixed to the anchor 4026or it can be operably connected and affixed to another metal component,such as the jackscrew traveler (not shown). Application of electrical RFpower to the electrical connector 4022 is in electrical communicationwith the inner tube 4024. A separate ground wire can be applied to thepatient. The electrical insulator jacket 4028 is optional but ispreferably affixed around the outer tube for its full length orsubstantially so. Thus, the inner tube 4024 ultimately receives the RFenergy and is the component that can burn or cauterize tissue. The innertube 4024 can be blunted, partially, or completely closed off at itsdistal end to render it maximally atraumatic.

FIG. 41 illustrates a steerable needle or axially elongate medicaldevice 4100 comprising a hub 4112, a fluid injection sideport 4102, astopcock 4104, a first control rod 4106, a second control rod 4108, aproximal port 4110, a piercing stylet 3500, an outer tube 4114, acontrol knob 4116 further comprising a pair of internal threads, anouter tube anchor 4118, an inner fluid tube or sleeve 4120, a secondjackscrew traveler 4122, a first jackscrew traveler 4124, and anoptional drive system 4126.

Referring to FIG. 41, the first control rod 4106 and the second controlrod 4108 are slidably, axially movably, constrained within the outertube 4114 and extend to or beyond the end of a distal bendable region ofthe outer tube 4114 (not shown). The outer tube is affixed to the outertube anchor 4118. The fluid-tight sleeve 4120 is a tube that isconstrained within the first control rod 4106 and second control rod4108. The proximal end of the fluid tight sleeve 4120 is operablyconnected to the sideport 4102 and the proximal port 4110 and is affixedto the hub 4112. The distal end of the fluid tight sleeve 4120terminates at or near the distal end of the device 4100. The hub 4112 isaffixed or integral to the stopcock 4104. The proximal end of the firstcontrol rod 4106 is affixed or integral to the first jackscrew traveler4124 and the proximal end of the second control rod 4108 is affixed orintegral to the second jackscrew traveler 4122. The first jackscrewtraveler 4124 comprises external threads that comprise a right handhelix. The second jackscrew traveler 4122 comprises external threadsthat comprise a left-hand helix. The control knob 4116 comprises distaland proximal extensions that further comprise internal threadsconfigured to engage with the threads on the jackscrew travelers 4122and 4124. Thus, the distal threads on the control knob 4116 comprise aright hand helix and the proximal threads on the control knob 4116comprise a left hand helix. The threads can, of course be reversed sothat the proximal threads are right hand helices and the distal threadsare left hand helices. The two control rods 4106 and 4108 and theirjackscrew travelers 4124 and 4122 can also be controlled with separatecontrol rod. However, the configuration illustrates provides for apush-pull arrangement that allows a single control movement to actuatethe control rods for simplest operation. The actuator 4126 can comprisea stepper motor and controller, a geared actuator, hydraulic pistons,pneumatic pistons, linear motor, and the like.

FIG. 42A illustrates a steerable medical device 4200, in its straight,unarticulated configuration, comprising a hub 800, a distal tip 4210, adistal bendable region 4202, a proximal bendable region 4204, anon-bendable intermediate region 4206, and a non-bendable proximalregion 4208.

Referring to FIG. 42A, the inner control rods or rods and keepers (notshown) preferably run substantially at least the entire length of thebendable regions 4202, 4204, and the intermediate non-bendable region4206. The proximal bendable region 4204 comprises two T-slots which areconfigured so that the lateral cuts in the outer tube close down andincrease flexural modulus in that area. The intermediate non-bendableregion 4206 retains a high flexural modulus. The distal bendable region4202 is configured with seven T-slots but this number can vary between 1and 20 with a preferred number of between 4 and 15. The width of thelaterally formed slots can be adjusted so as to maximize bendingstrength or flexural modulus. The T-slots in the proximal bendableregion 4204 are approximately 0.003 inches wide but can range from about0.001 inches to about 0.020 inches with a preferred range of about 0.001to about 0.010 inches, in the case of a 0.050-inch outer tube outsidediameter.

In order to maintain maximum resistance to prolapse when the bent orarticulated needle is forced against the septum, the slot widths andnumbers should be configured such that the tube will not articulatebeyond about 90 degrees and preferably less than about 85 degrees andmost preferably less than about 80 degrees. The narrower t-slots (about0.002 to 0.003 inches) are beneficial in that they reduce the occurrenceof yield in the outer tube relative to that which would occur with widert-slots, for example 0.009 inches wide, under high deflection bending.

FIG. 43A illustrates a steerable needle or catheter comprising a cuttingstylet 4300. The cutting stylet 4300 is illustrated with its cuttingelement retracted so as not to extend radially outward beyond theboundary of the cutting stylet 4300. The steerable needle or cathetercomprises the outer tube 4204, the distal end of the inner tube 4208,the distal tip 4210 of the inner tube 4208, a cutting stylet tube 4302further comprising a cutting stylet lumen 4318, a proximal cuttingstylet wire 4304, a sharp cutting wire segment 4308, a cutting stylettube window 4316, a cutting stylet wire distal end 4310, a sharp distaltip 4314 of the cutting stylet tube 4302, and a distal weld 4312.

FIG. 43B illustrates a steerable needle or catheter comprising a cuttingstylet 4300. The cutting element is illustrated as advanced or activatedradially outward so as to cut a larger incision in tissue than ispossible with an axially elongate stylet. The steerable needle orcatheter comprises the outer tube 4204, the distal end of the inner tube4208, the distal tip 4210 of the inner tube 4208, the cutting stylettube 4302 further comprising the cutting stylet lumen 4318, the proximalcutting stylet wire 4304, the sharp cutting wire segment 4308, thecutting stylet tube window 4316, the cutting stylet wire distal end4310, the sharp distal tip 4314 of the cutting stylet tube 4302, and thedistal weld 4312.

The cutting wire 4304 is actuated by distal advance of the cuttingstylet wire 4304 by actuation at the proximal end of the cutting styletsystem 4300. The weakened portion or segment 4308 selectively bends andthe window 4316 assists in guiding weakened portion 4308 radiallyoutward in a predictable direction. The cutting stylet system 4300 canbe fabricated from stainless steel, nitinol, titanium, cobalt nickelalloy, or the like. The cutting stylet system 4300 can further compriseradiopaque markers to assist with visualization of its operation andextent of position and advancement.

The cutting stylet 4300 can be actuated radially outward and it can beretracted radially inward and stowed for subsequent maneuvers includingadvancement and withdraw from the patient.

FIG. 44A illustrates the distal end of a steerable transseptal needle4400 further comprising a cutting stylet tube 4402, a window 4406 in thecutting stylet tube 4402, an actuator element 4404 further comprising asharp distal tip 4408, at least one expandable sharp elements 4412 and4414, the steerable transseptal needle distal end 4210, the distaltubing projection 4208, and the outer tube 4204. The control or actuatorelement 4404 is advanced and thus, the at least one expandable sharpelements 4412 and 4414 are not radially expanded because the distal end4410, to which they are attached is advanced distally.

The expandable sharp elements 4412 and 4414 can number from about 1 toabout 10 with a preferred number of between about 2 and about 4. Theexpandable sharp elements 4412 and 4414 are affixed at their distal endto the distal tip 4410 or a length of tubing affixed thereto. Theexpandable sharp elements 4412 and 4414 are affixed, or integral, attheir proximal end to the cutting stylet tube 4402. The expandable sharpelements can comprise malleable materials, spring biased materials, orshape memory materials. Materials of manufacture of the expandable sharpelements 4412 and 4414 can include but not be limited to, nitinol,titanium, stainless steel, tantalum, gold, platinum, platinum iridium,and the like, the latter four of which include enhanced radiopaqueproperties.

FIG. 44B illustrates the distal end of the steerable transseptal needle4400 further comprising the cutting stylet tube 4402, the window 4406 inthe cutting stylet tube 4402, the actuator element 4404 furthercomprising the sharp distal tip 4408, the expandable sharp elements 4412and 4414, the steerable transseptal needle distal end 4210, the distaltubing projection 4208, and the outer tube 4204. The control or actuatorelement 4404 is retracted, thus pulling the distal end 4410 proximallyand thus, the at least one expandable sharp elements 4412 and 4414 areradially expanded. The at least one expandable sharp elements 4412 and4414 are configured with sharp exterior edges capable of cutting animaltissue.

The advantage of this system 4400 is that it cuts an incision in tissueand not a puncture hole. The incision is capable of superior healing toa puncture hole and is also capable of expanding to permit passage oflarger instruments than would a puncture hole, especially in fibrous orscarred tissue.

FIG. 45 illustrates a steerable transseptal needle 4500 comprising theinner tube 4208, the outer tube 4204, and a piercing stylet systemfurther comprising a core structure 4502, a first cutting element 4506,a second cutting element 4508 and at least one cutting edge 4510disposed on the exterior of one or all of the cutting elements 4506 and4508. The cutting elements 4506 and 4508 are separated by the gap 4504which permits movement of one cutting element 4506 in a directiondifferent from that of the other cutting element 3508.

There can be one cutting element, two cutting elements as shown, ormore. Some or all of the cutting elements can comprise the sharpenededge 4510. The cutting elements 4506 and 4508 can be fabricated frommaterials such as but not limited to, nitinol, stainless steel, nitinol,and the like. Nitinol elements can be superelastic or shape memory inperformance.

The core structure 4502 translates longitudinally and slides within theinner tube 4208. The core structure 4502 can be manipulated by a usersince it extends from the proximal end of the steerable transseptalneedle 4500 to the expandable cutting elements 4506 and 4508. Retractionof the core structure 4502 can retract the cutting elements 4506 and4508 within the inner tube distal end 4210 completely. Advancement ofthe core structure 4502 exposes the cutting elements 4506 and 4508beyond the distal end 4210 and allows them to spring or move radiallyoutward to cut an incision larger than the diameter of the corestructure 4502, itself. The core structure can comprise a solid wire,tubular, or other cross-section.

FIG. 46 illustrates the proximal end of a steerable transseptal needle4600 comprising a hub 4602, a power supply 4604, a radiofrequencygenerator 4606, a switch 4608, a control knob 4610, an inner tube 4622,an outer tube 4624, an insulating cladding 4612, an adapter 4620 furthercomprising a side port 4614, a stopcock 4616 and a proximal port 4618.

The power supply 4604 can comprise batteries or it can be wired to anexternal source of electrical power. The radiofrequency (RF) generator4606 is powered by the power supply 4604 by way of a bus (not shown) andcan be turned on or off with the switch 4608. The output of theradiofrequency generator 4606 can be monopolar or bipolar and isoperably connected to the outer tube 4624, the inner tube 4622, or both.The insulating cladding 4612 surrounds the outer tube 4624 and can alsosurround the projecting part of the inner tube 4622 leaving a smallregion at the distal tip of the inner tube 4622 uninsulated so that theelectrical energy can be applied to tissue for cutting or cauterizingpurposes. In the case of a monopolar system, the patient can have anelectrode affixed to their skin, usually on their back to form a closedcircuit. The insulating cladding 4612 can be fabricated from materialssuch as, but not limited to, polyester, fluoropolymers, and the like.The steerable transseptal needle 4600 can be useful in cutting throughscarred tissue that resists normal needle punctures. The power supplycan be integral to the system 4600, as illustrated, or it can beexternal and wired to inner 4622 or outer tube 4624 through a busresiding within the hub 4602.

FIG. 47A illustrates a piercing stylet 4700 comprising an axiallyelongate tube 4702, a central lumen 4706, a sharp distal tip 4710, aradiopaque marker 4704, distal side openings 4708.

The radiopaque marker 4704 is encapsulated within the distal end of thestylet tube 4702 to minimize the risk of being dislodged. The radiopaquemarker 4704 can be welded, silver soldered, crimped, swaged, bonded, orotherwise fastened, to the stylet tube 4702. The side openings orwindows 4708 comprise perforations that permit fluid communicationbetween the central lumen 4704 and the exterior of the tubing 4702. Theradiopaque marker 4704 preferably resides distal to the one or more sidewindows 4708. The radiopaque marker 4704 can comprise a cylindrical rod,or other geometric shape, of materials such as, but not limited to,platinum, tantalum, platinum iridium, gold, barium or bismuth compounds,and the like. The stylet tube 4702 can be swaged or crimped at itsdistal end to cover the radiopaque marker 4704, to grip a depression inthe radiopaque marker 4704, or both, to prevent dislodgement of theradiopaque marker 4704 from the tube 4702. The distal end of the stylettube 4702, following having been reduced in diameter, can be furtherwelded to provide material for creating the sharp tip 4710. The tube4702, the marker 4704, or both, can be ground or otherwise formed into asharp tip with, for example, a conic, a faceted trocar, a bevel, or thelike.

Fluid injected through the central lumen 4706 can escape the centrallumen through the side windows, ports, or fenestrations 4708.Furthermore, the side windows 4708 can allow for pressure measurement bymeans of a pressure transducer operably connected to the central lumen4706 at the proximal end of the stylet or another location.

FIG. 47B illustrates the piercing stylet 4700 comprising the tube 4702,further comprising the central lumen 4706 and a tubing wall 4712, thehub 3500, and one or more proximal windows 4714 to allow for fluidcommunication between into the piercing stylet central lumen 4702 froman exterior port (not shown), which can, for example, be affixed andoperably connected to a hub (not shown) of a transseptal needle (notshown). The one or more windows 4714 can be formed into the tubing wall4712 by standard machining methods, such as, but not limited to, lasercutting, EDM, standard milling, photochemical etching, or the like.

Use of the system, as illustrated in FIGS. 47A and 47B, allows thecentral lumen of a transseptal needle to contain a large cutting orpiercing stylet without compromising the ability to measure pressure,inject fluid or withdraw fluid from a patient. The radiopaque marker4704 further permits the operator to visualize the distal-most cuttingpart of the system under fluoroscopy, which enhances the ability toprevent the system from cutting unwanted perforations in the patient'sanatomy.

FIG. 48A illustrates a proximal end of a steerable transseptal needle4800, in partial side cross-section, wherein the steerable transseptalneedle 4800 comprises an inner tube 4804, an outer tube 4802, a hub4806, a control knob 4808, a jackscrew traveler 4810, a spring 4812, anO-ring 4814, an O-ring retainer 4816, an inner tube anchor 4818, a hubto stopcock adapter 4820, and a stopcock 4822 (not sectioned).

The jackscrew traveler 4810 comprises threads on its exterior thatengage internal threads within the control knob 4808. The jackscrewtraveler 4810 is keyed such that it cannot rotate within the hub 4806.Thus rotation of the control knob 4808 causes the jackscrew traveler4810 to advance either proximally or distally. In the illustratedembodiment, the jackscrew traveler 4810 engages three threads within thecontrol knob 4808. Rotation of the control knob 4806 in a firstdirection causes the jackscrew traveler 4810 to advance distally. Theouter tube 4802 is affixed to the jackscrew traveler and thus movesdistally relative to the inner tube 4804, which is affixed to the anchor4818, which is affixed to the hub 4806 and the adapter 4820. Rotation ofthe control knob 4808 in a second direction causes the jackscrewtraveler 4810 to move proximally relative to the inner tube 4804. Sinceonly three threads are engaged, once the jackscrew traveler 4810 movesthree thread pitches proximally, its threads disengage from the threadsof the control knob 4808. Further rotation of the control knob 4808 doesnot result in any further proximal movement of the jackscrew traveler4810. Rotation of the control knob 4806 in the first direction,following thread disengagement, causes re-engagement of the threads ofthe jackscrew traveler 4010 to the threads of the control knob 4808,coerced by the spring 4812, which has become increasingly compressed bythe proximal motion of the jackscrew traveler 4810. This system isadvantageous relative to a hard stop because the jackscrew traveler 4810and control knob 4808 generate a large mechanical advantage that couldrip the hub 4806 and the adapter 4820 apart in the situation where ahard stop, or motion limiter, is employed.

FIG. 48B illustrates the proximal end of the steerable transseptalneedle 4800, in top view, wherein the steerable transseptal needle 4800comprises the inner tube 4804, the outer tube 4802, the hub 4806, thecontrol knob 4808, the hub to stopcock adapter 4820 further comprisingthe side port 4824 and a sealing cap 4826, and the stopcock 4822 furthercomprising the proximal through port 4828. The proximal through port4828 and the side port 4824 are in fluid communication with each otherbut can be separated by the stopcock 4822, as shown in the illustratedembodiment.

FIG. 49A illustrates a side view of a Side Window Introducer system4900, configured to deliver a steerable endoluminal punch or needle, inpartial cutaway section. The Wide Window Introducer system 4900comprises a sheath 4902, a dilator 4904 a sheath side window 4906 and adilator side window 4908.

The sheath 4902 comprises the side window 4906. The dilator 4904 alsocomprises the side window 4908. Both windows 4906 and 4908 can bealigned so that the needle 4910 can bend out of the longitudinal axis.

FIG. 49B illustrates a side view of the introducer system 4900 inpartial breakaway view, wherein a steerable endoluminal punch or needle4910 has been inserted and resides with its distal end within the areaof the windows 4906 and 4908. The needle 4910 tip can be aligned suchthat the entire bendable region of the needle 4910 or a portion thereofare within the windows 4906 and 4908 and thus permitted to articulate toat least some degree.

FIG. 40C illustrates the steerable endoluminal punch or needle 4910being articulated out through the side windows 4906 and 4908. With thesheath 4902 and dilator 4904 positioned within a body vessel, the sheathcan provide a backstop to permit the needle 4910 to be pushed laterallyagainst tissue to effect a perforation. Having both the region distalto, and proximal to, the bendable region of the needle 4910 provides formore backstop than if just the region proximal to or distal to theneedle 4910 are secured against a wall of a body vessel or lumen.

In other embodiments, the sheath 4902 and the dilator 4904 can beinserted into the body lumen and the dilator 4904 can be removed fromthe lumen of the sheath 4902 before inserting the needle 4910. In thisembodiment, the needle 4910 bendable region need be aligned within thesheath window 4906 without worry about alignment of the dilator window4908. Such alignment can be controlled, of course, at the hub end of thesheath 4902 and dilator 4904 with alignment keys or rotationalpositioning devices as well as longitudinal stops or keys.

FIG. 50A illustrates a steerable endoluminal punch or needle 5000comprising an outer tube 5004, a composite inner tube and pull rod 5002,which further comprises a lumen 5006, an end cap comprising a sharp tip5008, a hinge region 5012, and a gap 5010.

The hinge 5012 connects the inner tube 5002 to the end cap 5008 andpermits rotational motion about the axis of the hinge while retainingthe end cap 5008 firmly affixed to the inner tube 5002 distal end.

FIG. 50B illustrates the punch 5000 of FIG. 50A wherein a stylet 5014 orother control rod has been inserted into the lumen 5006 (See FIG. 50A)such that the stylet distal end resides adjacent the sharp, hinged endcap 5008.

FIG. 50C illustrates the punch 5000 of FIG. 50B wherein the styletcontrol rod 5014 has been advanced distally bending the hinge 5012,widening the gap 5010, and causing the sharp tip of 5008 to be moredistally forward oriented such that the sharp tip of 5008 is now in aconfiguration to cut tissue upon application of distal axial movementthan in its non-bent condition of FIGS. 50A and 50B. The hinge 5012 canbe a flexible strip of metal, polymer, etc. or it can comprise a pin andinterlocking receivers for each side. The hinge 5012 can be springbiased, magnetically biased, or the like. The end cap, or any of theother structures, can further comprise radiopaque markers (not shown)such as, but not limited to, tantalum, platinum, platinum iridium, gold,barium sulfate, and the like.

FIG. 51A illustrates a first step in generating a sharp distal end on atissue punch 5100 comprising an outer tube 5104, an inner tube 5102, anda truncated conical region 5106 at its distal end 5108.

The conical region traverses from the OD of the tube to the ID of thetube and provides increasing sharpness by minimizing the remaining wallthickness at the distal end. This reduced wall thickness also reducesany shoulders that might be forced against tissue to be perforated andmight therefore resist said tissue perforation. Ideally, the distalremaining wall thickness is approximately 0.001 or less.

FIG. 51B illustrates a second step in generating a sharp distal end on atissue punch 5100 comprising the outer tube 5104, the inner tube 5102, abevel 5110, the truncated conical region 5106, and a rounded, dulledheel region 5112.

The angle of the bevel 5110 can range between about 50 degrees and about10 degrees with a preferred angle range of about 40 and 25 degrees.

FIG. 52 illustrates the distal end of a steerable endoluminal punch 5100comprising the outer tube 5104, the inner tube 5102, the heel 5112, theconic section 5106, the sharp tip 5108, and a blunt protective stylet5202 further comprising a blunt, rounded end 5204, and a hub (notshown). The blunt protective stylet 5202 need not project too far outthe front of the distal end of the punch 5100 because it could causeprocedural problems, if too long. The blunt protective stylet 5202 canproject between about 1 mm and about 10 mm with a preferred range ofabout 2 mm to about 6 mm. Larger diameter stylets 5202 present a reducedgap between the stylet and the point of the needle and are thus, moreprotective than smaller diameter stylets 5202.

FIG. 53 illustrates a section of a human heart 5300 comprising a leftatrium 5308, a superior vena cava 5304, a right atrium 5302, an inferiorvena cava 5306, and an interatrial septum 5301. Also illustrated are theintroducer sheath system 4900 and the steerable endoluminal punch 4910of FIG. 49C.

Access can be gained through a subclavian vein or a jugular vein. Theintroducer sheath system 4900 can be routed over a guidewire, which isthen replaced with the endoluminal punch 4910. After the endoluminalpunch passes into the left atrium of the heart through the interatrialseptum 5310, a guidewire (not shown) can be passed through the centrallumen of the punch 4910 and be routed into the left atrium 5308 toestablish a pathway thereto.

Superior access, through the superior vena cava, to the left side of theheart entails use of a shorter catheter than access from the inferiordirection (through a femoral vein and the inferior vena cava). However,the geometries are such that the device needs to be angled quite morethan in the inferior approach. Thus a puncture device that is able toarticulate to about 90 degrees or more is beneficial. Furthermore thepuncture device needs to be able to generate lateral forces on theatrial septal wall after turning this sharp angle, and this usinggenerally axial movement on the part of the physician operator. The SideWindow Introducer 4900 provides a backbone against which a puncturedevice, such as the Steerable Endoluminal Punch 4910, can push.Additional stiffness can be added to the Side Window Introducer 4900such as, but not limited to, support bars, metal components in thesheath 4902 or dilator 4904, or radially enlargeable components such asballoons, expandable metal or plastic, or the like. This additionalstiffness can be added after placement of the Side Window Introducer topermit flexibility in access to a treatment site, in this case theinteratrial septum 5310. The Side Window Introducer can further compriseultrasound capability to provide for imaging at the point of treatment.Such ultrasound capability can include 2-D or real time 3-D imaging.

FIG. 54A illustrates the distal end of a steerable endoluminal punchcomprising an outer tube 5400 further comprising a plurality of radiallyoriented slots 5410, optionally comprising strain reliefs on each slot.The punch 5400 further comprises an inner tube 5402, a 4 pointed crowndistal end 5406, and sharpened edges of the crown 5408.

FIG. 54B illustrates the distal end of a steerable endoluminal punchcomprising an outer tube 5420 further comprising the plurality ofradially oriented slots 5410, optionally comprising strain reliefs oneach slot. The punch 5420 further comprises an inner tube 5422, a 2pointed crown distal end 5426, and sharpened edges of the crown 5428.Note that in FIG. 54B, the T-slot is oriented 90 degrees toward theviewer relative to its orientation in FIG. 54A. The steerableendoluminal punch 5420 articulates within the plane of the paper in FIG.54A, whereas the steerable endoluminal punch 5420 articulates up out ofthe plane of the paper in FIG. 54B. The illustrated orientations arepreferred embodiments.

The distal end of the steerable endoluminal punch can comprise anynumber of points between 1 and about 10 but more preferably betweenabout 1 and about 4. Another embodiment comprises a distal end having athree-pointed crown (not shown). The blunt stylet 5202 (see FIG. 52) canbe used to shield the sharp crown points from the walls of a catheter ordilator through which it might be passed.

FIG. 55 illustrates the distal end of a steerable endoluminal punchsystem 5500 comprising a cutting stylet 5502, further comprising a sharptip 5504, one or more laterally biased cutting blades 5506 furthercomprising one or more sharp edges 5508, the inner tube 5402, the outertube 5404 further comprising a plurality of radially oriented slots5410, a hub (not shown) at the proximal end which may or may not bespring loaded, and a distal end 5408 comprising one or more sharp edges5406. In the illustrated embodiment, the two cutting arms 5506 are ableto be squeezed together for insertion into the lumen of the inner tube5402 by the user. The arms 5506 are biased outward so that when advancedbeyond the end of the inner tube distal end 5408, they can springoutward (or be forced outward with a control rod) to cut a largerincision in tissue than would be possible with the native diameter ofthe cutting stylet 5502. This embodiment is especially useful forcutting a sufficiently large incision through which to pass the innertube 5402, the outer tube 5404, and any sheaths and dilators disposedthereover, especially in very elastic tissue, scar tissue, or thickenedtissue.

A primary issue with an endoluminal punch, or needle, is that itgenerally creates an incision or hole in tissue through which acatheter, dilator, or other axially elongate instrumentation is to beadvanced. Creation of an incision that is large enough for theendoluminal punch to pass, does not guarantee that larger diameterdevices riding over or on the endoluminal punch will be able to passthrough this small incision or hole. Thus, it can be beneficial, or evenmandatory, to create an incision that is larger than that needed for asharp stylet and larger than that needed for the endoluminal punch topass through the hole so that a catheter, dilator, or combinationthereof, to pass through the hole. The expanding sharp stylet canaccomplish this. Application of electrical energy, such asradiofrequency energy, at the tip of the endoluminal punch can performthis hole enlargement by weakening the tissue in a tissue penumbraaround the needle tip. This is especially important when the tissue isscarred, thickened, or extremely elastic. Punching a hole in such tissueand then dilating that hole up to a larger diameter by tapered dilatorscan stretch the tissue and locally increase its resistance to furtherpenetration. An introducer comprising a small cutting element at itsdistal end, near or on the dilator taper region, can provide foradditional tissue incision and permit the larger diameter catheter anddilator to pass through an enlarged incision. The cutting element on theintroducer or its dilator can be operated from the proximal end throughuse of a control rod or wire or by selective use of the blunt stylet, acutting stylet, or both, such that the cutting element stays retractedand is only activated when desired, by user control.

FIG. 56A illustrates a cutting introducer 5600 comprising a sheath 5602,a tapered dilator 5604 further comprising a secondary lumen 5606,through which is slidably inserted a cutting instrument 5608. Thetapered dilator 5604 further comprises a central lumen through which isslidably and removably inserted an endoluminal punch 5610. Theendoluminal punch 5610 further comprises a small diameter distal tubingprojection 5612 tipped with a sharp end 5614. Also illustrated is apiercing stylet 5616 further comprising a sharp trocar distal tip 5616,which is slidably inserted through a central lumen of the endoluminalpunch 5610. The cutting instrument 5608 is configured to be selectivelyadvanced, when needed, to assist with cutting an incision bigger thanthat which can be cut by the sharp end 5614 and the piercing stylet5616.

FIG. 56B illustrates a cutting introducer 5630 further comprising theintroducer sheath 5602, a dilator 5624 further comprising a cuttingelement lumen 5622 and a cutting element 5620. An endoluminal punch 5610is inserted into a central lumen of the dilator 5624. The optionalpiercing stylet 5616 is inserted through a central lumen of theendoluminal punch 5610. Distal end of the larger diameter portion of theendoluminal punch 5610 is configured to engage the proximal end of thecutting element 5620 and force it distally thus exposing its distalsharp end to assist with tissue incision. The cutting element 5620 istrapped within the cutting element lumen 5622 and cannot be removed fromthe system. The cutting element 5620 is preferably biased in itsretracted position by a spring (not shown) or other biasing element.

The steerable needle, in other embodiments, can comprise monitoringsystems to measure, display, announce, record, or evaluate operatingparameters of the steerable transseptal needle. In an embodiment, thesteerable transseptal needle can comprise strain gauges to measure theforce being applied by the user to bend the needle. A torque gauge canalso be comprised by the system to measure torque being applied to thecontrol knob or the torque being applied by the distal curvaturemovement. The strain gauge or torque gauge can be affixed within the hubor elsewhere within the steerable transseptal needle to measurecompression or tension forces. This information can be displayed in theform of a readout device, such as a digital display of the force ortorque. The number of turns can be counted and displayed by, forexample, a Hall-Effect sensor, mechanical counter, or the like. In anembodiment, the force or toque can be correlated to the angle ofdeflection at the distal end, the number of turns applied to the controlknob, or both. The readout can be digital or analog and can be affixedto the hub or can be wirelessly received and displayed on externalequipment such as a smart phone, computer, tablet computer, paneldisplay, or the like. The wireless technology can, for example, compriseWi-Fi, Bluetooth®, or other standardized protocols. The human interfacecan, in other embodiments, comprise audible feedback such as a simplebeep or tone, or it can be more sophisticated and provide informationusing language callouts such as force, turns, torque, or the like.

In operation, the system operates similarly to the standard steerabletransseptal needle with a few exceptions. The procedure is to advance asteerable transseptal needle, with a tissue piercing stylet affixed inplace, through a transseptal introducer that has already been placed.The steerable transseptal needle is articulated to generate the propercurve, as determined under fluoroscopic or ultrasound guidance. Thesteerable transseptal needle transseptal introducer assembly iswithdrawn caudally out of the superior vena cava and into the rightatrium of the heart. Proper location, orientation, tenting, and otherfeatures are confirmed. Radiopaque dye can be injected through thesteerable transseptal needle to facilitate marking of the fossa ovalisor blood flow around the distal end of the steerable transseptal needle.Pressure measurements can also be taken through the lumen of thesteerable transseptal needle to confirm tracings consistent with theright or left atrium of the heart. Once proper positioning has beenconfirmed, a safety is removed from the stylet hub and a button on thestylet hub is depressed or actuated to cause the sharpened stylet tip toadvance out beyond the distal end of the steerable transseptal needle.This sharpened stylet punches through the fossa ovalis and the septaltissue pulls over the stylet, over the inner tube, and over theobturator or dilator of the transseptal introducer. At this point, thesharp stylet is released and retracts proximally within the steerabletransseptal needle. The transseptal introducer is now within the leftatrium of the heart and the steerable transseptal introducer can bewithdrawn from the lumen of the obturator.

The present invention may be embodied in other specific forms withoutdeparting from its spirit or essential characteristics. The describedembodiments are to be considered in all respects only as illustrativeand not restrictive. For example, the deflecting wires 412 can bereplaced by an electromechanical actuator and external control unit.Control over forces applied to the hub, including relative forceapplication to the inner and outer tubes and control rods and rotationof the system about its longitudinal axis can be controlled byelectromechanical actuators and computerized controllers, or the like.

We claim:
 1. An apparatus adapted for punching a hole in a body lumen orhollow organ of a mammal comprising: an outer axially elongate hollowtube having a proximal end, a distal end, a longitudinal axis, and alumen extending therethrough; an inner tube divided, axially, into atleast one control rod and a partially disconnected keeper within aspecified bendable region; a plurality of laterally oriented slitsextending partway into the outer tube within the bendable region but notcompletely transecting the outer tube; a hub affixed to the proximal endof the inner tube, wherein the hub comprises an internal lumen capableof receiving a control mechanism, wherein the outer tube is constrainednot move relative to the hub; and a connection between the inner tubeand a point of the outer tube distal to the plurality of laterallyoriented slits in the bendable region.
 2. The apparatus of claim 1further comprising a short, rounded, removable, protective styletprojecting out a distal end of the inner tube to shield surroundingstructures from a sharp distal end of the apparatus.
 3. The apparatus ofclaim 1 further comprising a removable piercing stylet capable ofpunching through tissue more sharply than a native distal end of theapparatus.
 4. The apparatus of claim 3 wherein a distal end of thepiercing stylet is capable of expanding radially outwardly to increasethe size of an incision created by the apparatus.
 5. The apparatus ofclaim 1 wherein the distal end is formed into a crown configurationcomprising at least two sharp points.
 6. The apparatus of claim 1wherein the distal end comprises a conical configuration to minimizewall thickness at a tip of the outer tube and bring a sharp regionradially inward away from the walls of a catheter or dilator throughwhich it can be introduced.
 7. The apparatus of claim 6 furthercomprising a bevel to generate a sharp distal point located radiallyinward from an outside diameter of the inner tube.
 8. The apparatus ofclaim 6 further comprising at least two points configured as a crown. 9.The apparatus of claim 1 further comprising a distal tip which ismovable from a first blunt configuration to a second sharp configurationby action of a user at a proximal end of the apparatus.
 10. Theapparatus of claim 9 wherein a control rod is configured to move thedistal tip from the first blunt configuration to the second sharpconfiguration and further comprises a lumen for flow of fluids orpressure measurement.
 11. The apparatus of claim 1 further comprising aSide Window Introducer comprising an axially elongate sheath and anaxially elongate dilator configured to slidably and removably engage thesheath, wherein the sheath and the dilator comprise at least one sidewindow proximate their distal end, further wherein the side windows ofthe sheath and dilator can be aligned with each other to provide a sideport through which the apparatus of claim 1 can articulate out of thelongitudinal axis.
 12. The apparatus of claim 1 wherein the distal endcan controllably curve between about 0 and at least about 90 degreesfrom the longitudinal axis.
 13. The apparatus of claim 1 furthercomprising a pressure jacket disposed exterior to the outer tube whereinthe pressure jacket prevents ingress or egress of fluid through afenestrated wall of the apparatus.
 14. The apparatus of claim 1 furthercomprising an innermost tube, further comprising a proximal end, adistal end, and a lumen therethrough, disposed interior to the outertube and preventing the ingress or egress of fluid from the lumen of theouter tube.
 15. The apparatus of claim 1 further comprising one or moreradiopaque markers capable of enhanced visibility under fluoroscopy. 16.The apparatus of claim 1 wherein relative forces generated on the innertube and outer tube are determined by commands generated by a computeror robotic device and delivered by a force generating mechanism coupledto the computer or robotic device.
 17. The apparatus of claim 1 whereinfurther comprising a fluid flow channel around or within a sharpenedstylet, the fluid flow channel being operably connected to a port on thehub of the apparatus.
 18. The apparatus of claim 1, further comprising acentral stylet that is sharpened and configured to punch tissue, saidstylet being constrained within a lumen of the inner tube to beretracted within the inner tube until activated.
 19. The apparatus ofclaim 1 wherein a distal end of the inner tube is blunted and taperedinto a conic shape.
 20. The apparatus of claim 1 wherein a stylet hub isaffixed to a proximal end of a central stylet, said stylet hub beingconfigured to be releasably affixed to a needle hub.
 21. The apparatusof claim 20 wherein the stylet hub comprises a control mechanism tofacilitate advancement of the stylet beyond a distal end of the innertube in a momentary fashion.
 22. The apparatus of claim 1 furthercomprising an electrical pathway between an external electrical powersource and a distal tip of the apparatus.
 23. The apparatus of claim 22wherein the electrical power source operates in the radiofrequencyrange.
 24. The apparatus of claim 22 wherein the electrical power sourceprovides sufficient current as to cut through tissue.
 25. The apparatusof claim 22 wherein the electrical power source provides sufficientcurrent as to cauterize tissue.
 26. The apparatus of claim 1 furthercomprising a cutting stylet configured to cut a wider incision than anoutside diameter of the outer tube.
 27. A method of accessing a bodycavity or lumen comprising the steps of: Introducing a catheter into amammalian body from a superior approach through an access channel;Wherein the catheter comprises at least one side window; Advancing asteerable endoluminal punch such that a bendable region is aligned withthe side window in the catheter; Bending the bendable region of thesteerable endoluminal punch such that a tip of the steerable endoluminalpunch is forced radially outward away from an axis of the catheter;Producing axial force on the endoluminal punch; Generating off-axisforces at the tip of the steerable endoluminal punch by forcing thecatheter into a wall of the access channel; Puncturing a target regionin the mammalian body with the steerable endoluminal punch distal end;Inserting a guidewire through a center channel of the steerableendoluminal punch; and Removing the steerable endoluminal punch leavingthe guidewire in place.
 28. The method of claim 27 further comprisingthe step of inserting a dilator into a central lumen of the catheterprior to advancing the steerable endoluminal punch into the catheter.29. The method of claim 27 further comprising the step of inserting adilator into a central lumen of the catheter wherein the dilatorcomprises a side window that can be aligned with the side window of thecatheter.
 30. The method of claim 27 further comprising the step ofbending the steerable endoluminal punch to approximately 90 degrees orgreater from the axis of the catheter.